Home > Transparency Posts > Introducing the FDA Transparency Blog

Introducing the FDA Transparency Blog

I want to thank Peggy Hamburg and the team at FDA for their leadership and work to make the FDA open and transparent.

Our Administration is committed to eliminating the barriers between the American people and their government, and the Task Force is another big step in the right direction.

The FDA is responsible for protecting the food we eat and the medicine we use — its work impacts every American, and ensuring the agency is open and accountable to the American people is critical.

Thank you for taking the time to visit the Task Force blog and learn more about this effort.  We appreciate your thoughts and ideas and look forward to hearing from you.

Sincerely,

Secretary Kathleen Sebelius 
U.S. Department of Health and Human Services

Background
Providing information to the public in a user-friendly and timely manner is critically important to the work of the agency and its credibility with the public.  I have formed a Transparency Task Force, chaired by Principal Deputy Commissioner Dr. Joshua Sharfstein, to provide me with recommendations about how to make FDA and its processes more transparent to the public.

If you have a suggestion about how to improve transparency at the agency, I encourage you to let the Task Force know by submitting or responding to a comment in the blog provided below.

In addition to this blog you can also submit electronic comments to the federal register at www.regulations.gov, submit written comments to the Division of Dockets Management, or attend a public meeting on Wednesday, June 24, 2009 in downtown DC with some members of the Task Force.  Additional details about how you can engage with the Task Force can be found here. The first blog post is to inform you of this process and our policy.  Thereafter, we will be asking for you feedback on specific topics.

Thank you for your input and participation.

Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs

Comment Policy
This is a moderated blog. We expect that participants will treat each other with respect. All comments will be reviewed before posting. We will not post comments that contain vulgar or profane language; personal attacks of any kind; or offensive terms that target specific ethnic, religious or racial groups. We will not post comments that are clearly off topic, spam, or that promote services or products. Comments that make unsupported accusations will also not be posted.

Reporters are asked to send questions to the FDA Media Office through their normal channels and to refrain from submitting questions here as comments. Reporter questions will not be posted.

We recognize that the Web is a 24/7 medium, and your comments are welcome at any time.  However, given the need to manage federal resources, moderating and posting of comments will occur during regular business hours Monday through Friday.  Comments submitted after hours or on weekends will be read and posted as early as possible the next business day.

For the benefit of robust discussion, we ask that comments remain on-topic.

To protect your own privacy and the privacy of others, please do not include phone numbers or email addresses in the body of your comment.

Thank you for taking the time to read this comment policy. We encourage your participation in our discussion and look forward to an active exchange of ideas.

  1. dave
    June 2, 2009 at 10:48 pm

    FDA’s lost its way and must go back to the original intent to find it.
    Without that, FDA’s been left alone too long pursuing its own goals and now can’t find its way home.
    Who will lead FDA back home? The transparancy police?
    Not likely.

    • February 8, 2011 at 5:49 am

      This open forum is a great first step to transparency, but FDA should also info on the manufacturing industries they regulate. An online hotline will also help consumers in reporting illegal products.

      -Bianca of Eton Properties

  2. Brook C.
    June 3, 2009 at 12:25 am

    It is good to see the US government willing ot embrace a technological transparency, but the tricky question is can you manage expectations of the American consumer? what are the current limits of the FDA and how do you guys propose to make sure all the food in North America stays safe?

  3. Wardo
    June 3, 2009 at 10:19 am

    Transparency to the American public is a fine goal and I applaud your efforts to do this in an online forum. However, the industries you regulate need the FDA to be transparent as well.
    Due to lack of formal policy on topics like online advertising, medical and pharma industries have to second guess the FDA’s stand on many emerging issues. It’s a bit like driving on a road with no posted speed limit – where the limit is established by the first person to get a speeding ticket (or in this case an FDA Letter).
    I have worked in the medical device industry for several companies. I’m sure we are all looking forward to a clearer path.

  4. Marion Nestle
    June 3, 2009 at 11:48 am

    With respect to the safety of the food supply for people, farm animals, and pets: the FDA’s web pages on specific outbreaks are exceptionally helpful and should be continued, expanded, and kept up to date. I have three specific suggestions: (1) Publish an explanation of what the FDA is not permitted to disclose, and why, (2) Put all documents on the web and improve the indexing and search functions so it is easier to find them, and (3) Appoint an ombudsman to facilitate responses to consumer concerns about lack of transparency.

  5. Rohit Bhargava
    June 3, 2009 at 12:54 pm

    Congratulations on launching this blog! Like most fellow bloggers, the one thing I know well is that launching a blog is only the beginning. Keeping it up to date and living up to the mission you have shared for it will be the real test, and I look forward to reading and seeing how you will meet it. Unlike some other commenters, I feel optimistic that this blog exists and that the FDA is moving towards a more open and transparent existence. It may not be easy, but is definitely a challenge worth taking.

  6. Dr. Michael Rushnak
    June 3, 2009 at 1:25 pm

    The Obama Administration is to be highly commended for their righteous efforts in assembling a team at HHS and the FDA who will strive to improve the transparency of our federal agencies to the American public. Based on prior events, the trust of the public with the actions of the FDA has been waning in recent years.
    As a physician for 35 years, I feel strongly that the FDA needs to return to its roots as our consumer protection agency for ensuring that medications, medical devices, and food are approved for safe consumption by the public.
    I applaud your efforts in opening a dialogue with the public to re-build the trust of the American people. Thank you.
    Michael Rushnak, M.D., M.P.H.

  7. Eric Abraham
    June 3, 2009 at 2:01 pm

    The FDA has a tough job ahead of itself. It has to provide safeguards for society against crude forms of food and drug adulteration (i.e., filth and lack of quality in manufacturing) while also spearheading the future as it may relate to drugs/products of the 21st century (i.e., drugs customized based on a persons physiology and genetics). These two areas require different resources and approaches. The first is heavily dependent on inspections and ‘being there’ while the second requires a rare brain trust. The prior commissioner was a proponent of the second while not putting resources into the former (hence the problems due to lack of inspections and enforcement of GMP).
    I doubt that transparency will help.
    It may be time to split the agency so that the groups can properly focus on different areas.

  8. Avery
    June 3, 2009 at 5:01 pm

    As a consumer with no interest in pseudoscience or alternative medicine, I still have very little faith in the FDA, simply because its recent failures are much more obvious than its successes. Transparency can do a lot to change that. I note that the tools to examine drugs, foods, and regulatory actions are already available in the depths of the FDA website– the job of the transparency team should simply be to make these easy to use. Good luck!

  9. Erick Turner, M.D.
    June 3, 2009 at 5:43 pm

    Thank you for opening this conversation.
    The FDA has been sitting on decades of clinical trial data, much of which has never seen the light of day. As we showed in an article in the New England Journal of Medicine — http://content.nejm.org/cgi/content/abstract/358/3/252 — FDA data can be used to “debunk” the rosy picture of drug efficacy that often gets conveyed in medical journal articles.
    Unfortunately, access to this FDA data through the Freedom of Information Act leaves much to be desired. For more information on this, please see the Obstacles and Limitations section of the essay at http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0010060 .
    Thanks again for opening this public conversation. It bodes well for the public health.
    Erick Turner, M.D.

  10. Mark A
    June 4, 2009 at 10:33 am

    I think this is a great initiative. As a current student enrolled in pharmacy school, I am excited to see where the future is heading.
    One of the challenges I see are actually reaching out and letting the public know about your initiatives. I only knew about this because my preceptor e-mailed me about the conference call yesterday. Any help with this, please let me know.
    Thanks again for your efforts!

  11. Gareth Sparks
    June 4, 2009 at 10:39 am

    I have to congratulate the FDA and the OM for the work they’ve already done to improve transparency at the FDA over the past months. Until May, the website was a hodgepodge of staff listings and organizational charts from 2007 and beyond, riddled with dead links and bad information. Well okay–so there are some dead links now too–but that’s because it’s a work in progress. And your efforts toward progress are appreciated.
    The criticisms the FDA has suffered can be resolved best with exactly this kind of effort toward true transparency. Opening the agency’s doors and windows can do a lot to dissolve the perception that it has become a corporate structure, rather than a guardian of the American people. Funding is clearly a major issue too–but this renovation of the FDA’s image through earnest reform will help the agency to gain the public trust, which in turn might help to justify greater appropriations.

  12. RC REDDY
    June 4, 2009 at 11:50 am

    This decision by FDA is welcome.Hope it,as pointed by secretary of HHS ,will eliminate the barriers between the govt.and people.

  13. Jill Wahleithner, PhD
    June 4, 2009 at 11:54 am

    Thank you for setting up this forum.
    It’s my opinion that the FDA suffers from allowing companies to control the information flow. Since most communication about approved drugs is available on-line, I am concluding that the lack-of-transparency-complains are aimed at clinical trials, pre-approval communications between the agency and companies, and the approval process. Why does the release of all pre-approval information have to be under the control of the companies? My suggestion would be to introduce a step-by-step process where once end-of-phase meetings and documents are finalized the information is published on-line. In addition, an NDA cannot be approved until a company has made all clinical trial reports for that drug available on-line at the NIH clinical trials site.

  14. H. Hackett
    June 4, 2009 at 12:16 pm

    It’s nice to see that there are changes in place and that perhaps now the FDA can get back to being an efficiently run department without all of the delays, holdups, secrecy, etc. surrounding the decisions and management choices made.

  15. Scott S
    June 4, 2009 at 12:30 pm

    I have to agree with Erick Turner, the FDA has decades of clinical trial data which has never, ever been made public, even though the patents on these drugs have long since expired — decades ago.
    I suggest the FDA adopt a policy for not harboring any clinical trial data beyond the patent’s expiry … it should be in the public domain well before, but there’s absolutely no reason for keeping it after that.
    I appreciate your efforts to make the agency more open, but there is so much to be done. In fact, the U.S. Patent and Trademark Office releases far more drug-related information than the FDA currently does, which is an indication of just how much this agency really needs to change.

  16. E. Michael D.("Mike") Scott
    June 4, 2009 at 12:49 pm

    So … the past is the past and we ALL should seek to work cooperatively with the FDA as it tries to move into the future. This will also require us ALL to put aside our prejudices and preconceptions and to collaborate in the public interest.
    I would like to strongly suggest three priorities in optimizing FDA transparency, as follows:
    1. BRIEF, WRITTEN decision summaries that provide publicly available information about ANY FDA decision that has significant impact on access to drugs, including approvals, withdrawals, policies, etc. Ideally such written decisions should be available in both the Federal Register and on the FDA web site and should be written in such a way as to be understandable to at least the intelligent lay person (as opposed to lawyers and regulatory specialists). I see no reason why such decision summaries ever need to address specific data that may be confidential.
    2. REGULAR statements from the FDA, similar to the recent article by Drs Hamburg and Scharfstein in the NEJM (an EXCELLENT beginning, by the way), that offer clear outlines on FDA policies that affect the public health and which allow the public to understand how FDA leadership is attempting to influence the transition of the FDA back to being one of the world’s most respected public health agencies.
    3. A CLEAR and FORTHRIGHT policy that ensures public access in a simple and clear manner to ANY policies proposed by the Executive branch or by Congress to influence FDA decision making, so that the American public can be aware of such influence and decide for themselves whether such influence is in the interests of the public health in general (as opposed to some specific interest group).
    It would help if some form of external “transparency monitoring” or advisory committee could be put in place to give guidance to the FDA on what was needed — and if that advisory group included some people who came from well beyond the “usual suspects” that have historically attempted to exert influence over the FDA (from Public Citizen at one end of the spectrum to the Washington Legal Foundation at the other).
    Respectfully
    E. Michael D. (“Mike”) Scott
    Principal, Vox Medica Holdings, Inc.
    Member, Board of Directors, the International Myeloma Foundation
    and
    President and Co-Founder, Prostate Cancer International

  17. Mary Pendergast
    June 4, 2009 at 3:42 pm

    I suggest that the Office of the Chief Counsel for FDA post onto the FDA’s web site all of the briefs that are filed by that office (through the Department of Justice) in all cases. Other federal agencies do it, and, except in very rare cases, they are publicly available through the courts (for a fee). It would be a service to everyone who cares about how FDA is enforcing the law.
    I also suggest that everytime FDA answers a FOIA request, it immediately post that information onto the FDA web site. That way, other people will have access to the same information, and FDA will not have to answer repeated requests for the same information.
    Finally, I suggest that FDA take a look at why it takes so long for the decision memoranda in support of a drug approval to be posted. FDA should consider having an internal deadline of two weeks from the time it makes a drug approval decision to when the review is posted.

  18. Daisy
    June 4, 2009 at 6:05 pm

    I suggest that FDA post all their responses, status and correspondences for easy finding/viewing when importers are looking for information regarding their entries. Whether FDA is pending, released or EXAM. That way importers can contact the correct person or offical in charge of their entries when questions arise.
    I suggest that FDA posts updated status of existing FDA EXAM/DETAIN entries and make available for importers to check themselves other than relying on the FDA Status Hotline.
    I suggest FDA provide importers an easy and convenient method of contacting FDA to request for re-evaluation on certain entries when a medical device is being labelled “FDA EXAM” while the same device is already being examed by FDA in the same month.
    Finally, I suggest that FDA take a look at why it takes so long for the FDA decision/released to be made after samples are picked up. We had cases before where after we rushed the private lab testing result out it still took almost a month to review the result before it got released. FDA should consider having an internal deadline from the time samples are picked up to when a decision is posted.

  19. Bray Patrick-Lake, patient advocate
    June 4, 2009 at 11:34 pm

    Thank you for launching this blog. I have sent correspondence to Ashley Boam, Chief, Interventional Cardiology Devices Branch, asking for more transparency and inclusion of patient voice in the development of medical device trials, particularly related to PFO/Migraine research. I appreciate Commissioner Hamburg tackling this issue. The effort to include comments from the public in this discussion is a pleasant and exciting change.

  20. Melody Hoadley
    June 5, 2009 at 9:06 am

    Transparency is a terrific idea . . . but I assume you intend to address the issue GOING FORWARD? What about hindsight transparency? What about a look back at the approval process that placed speed before safety?
    I speak of the past because it sets the standards for the future. I speak of the past because for almost 3 decades a subset of patients—many of them ‘square pegs’—have been forced into a ‘round hole’ circumscribed by insulin producers with the blessing of FDA.
    rDNA insulin—the FIRST biotech drug to gain FDA approval—was approved in a mere 6 months at a time when most drug approvals took 18 to 24 months. This first-of-its-kind drug did not even have a ‘category’ within the FDA, and consequently, rDNA synthetic ‘human’ insulin was approved under guidelines used for small molecule drugs such as aspirin.
    A controversy now exists where insulin producers—seeking to prevent generic production/competition—have testified before Congress that THEIR biotech drug(s) are comprised of such complicated proprietary information that NO generic manufacturer can perfectly and safely duplicate their product in a generic version. What they did NOT tell Congress is that biotech drugs (including insulin) have downstream genetic proteins, produced by the host transgenic molecule. This precludes them from insuring the bioidenticality of their own product(s) from batch to batch . . . surely a case of the pot calling the kettle black. Without looking back and identifying flaws that existed BECAUSE the fledgling biotech industry was making up rules as it went along, future guidelines may be founded on an ill-advised or flawed base, perpetuating continued flawed methodology. Can we hope for historic transparency, too?

  21. Lorrie Hellier
    June 5, 2009 at 1:56 pm

    The FDA needs to be more open about issues related to unapproved drugs. IN a particular case of a dental drug/device, with which I was permanently and severely harmed, the material was rejected for approval in 1993, yet the use of it continues concealed from the patients and the regulators. Compounding pharmacies are making and selling it in bulk across state lines and has so for decades. I believe that the FDA owes it to the consumer to alert them that issues like this are on going so that they are able to protect themselves or atleast make educated choices. The FDA has put alot of effort into notifying the public about mercury in fillings, lead in dental products from China but has done nothing to inform the public about formaldehyde, lead and mercury in root canals. If the laws are not going to be enforced, the FDA should be obligated to alert the public.

  22. Daniel A. Casciano
    June 5, 2009 at 5:29 pm

    As a retired FDA employee, I applaud the intent of this blog. It is refreshing to see an administration that is supportive of science because the FDA is a science-based agency and cannot realistically function if the political appointees abhor science. I think that one consideration of the new FDA administration is to find a simple mechanism of communicating with the public and to do this in plain language. This requires overcoming the FDA culture that is directed toward compliance and not explanation. I suspect that most citizens receive their information about the agency via Lou Dobbs, who doesn’t understand government much less the mission of this regulatory agency. In my opinion, neither the FDA Consumer nor the web site fulfills the needed communication link to the public. The FDA’s mission to promote and protect the public health will be more complicated with the additional responsibility to regulate tobacco industry,

  23. Jim Dickinson
    June 8, 2009 at 2:33 pm

    I strongly support this initiative, and most of the comments and suggestions that have been made on the Weblog to this point (I have read them all). It is clear that a diverse constituency is dissatisfied with the state of FDA’s transparency, and has been for a very long time.
    While I share all of the concerns, my own ongoing concern is the inhibition of FDA employees generally when it comes to freely giving their ideas and opinions to the news media.
    As a journalist, I have been dealing with FDA employees since 1974, and I have witnessed the growth of this inhibition from a general easiness (sure, some people fear the press and think reporters can’t ever get anything right) to an almost universal paranoia about what talking to the press will do to their careers.
    Such a fear is normal in a minority of any group. But at FDA it is a fear held by the overwhelming majority, and it is in my view a sign of an unhealthy workplace, where management retribution is routinely expected.
    It is also a fear that is greatly amplified by a relatively new management policy of channeling all conversations with the news media through the FDA Press Office. In this way, managemement effectively eavesdrops on all such conversations, and free expression of personal opinions with reporters is constrained or eliminated.
    Many FDA employees believe their emails and telephone conversations are always monitored or at least subject to surprise audits.
    Installing the FDA Press Office as the single spigot for FDA information reaching the news media, and through the media, the wider world beyond, is the antithesis of transparency. It flies in the face of both the First Amendment, and Thomas Jefferson’s immortal words that, were it up to him to decide between a government with no news media, or news media with no government, he would not hesitate to choose the latter.
    Yes, the news media have many deficiencies, and accuracy is a frequent casualty in our reporting. But FDA and everyone else also have deficiencies as well.
    Intimidating FDA employees out of the First Amendment right to speak to the news media, and attempting to confine the news media to the single spigot of the FDA Press Office in hearing from those employees is a bad policy that hurst everyone.
    I have heard the management objection, expressed with a little hyperbole, that they can’t have employees being distracted from their work by hordes of reporters calling them willy-nilly. That didn’t happen before the single-spigot policy was introduced, and with the contraction of media outlets and the growth of the Internet, it is an unlikely concern.
    I have also heard the objection that most employees don’t know enough about a topic to be a reporter’s unguided source of reliable information. With respect, under the First Amendment, it is not the government’s function to preempt that problem, if it is a problem (which I doubt, based on my 35 years of experience reporting FDA employees).
    The only justification for the single spigot policy is to control both the media and their sources within FDA. Neither fits well with the laudable goal of better FDA transparency.
    Jim Dickinson, Editor
    FDA Webview (www.fdaweb.com)

  24. CMCguy
    June 8, 2009 at 4:45 pm

    The “new” openness really needs to start first with the FDA as so much of the “rational” behind their decisions is indeed a “black box” even to those in industry who interact with them constantly. Even when following Guidances there are still many things in a submission that are subject to interpretation so approach approval with uncertainty on how Agency will handle. One would trust FDA could demonstrate core scientific basis to decisions (or other “good explanations”) rather than the political or mysterious bureaucratic motivations that appear to dominate thinking. At times potential benefits to patients appear to “get lost” in a overly stringent statistical dogma because those outcomes do not fit in to standards for objective criteria/interpretations.
    There does need to be better collaboration with FDA & Industry in the whole process and release of certain info could be more forthright. In particular companies should publish CRLs, perhaps with some elements redacted, to clarify why “non-approvable”, although underlying issue is effect of stock which is unpredictable in most cases.
    I do see a several legitimate reasons to keep manufacturing and clinical info secure from Industry perspective. Competitors could use such info for advancing their own programs or in marketing “against” the other companies post-approval. Often data is incomplete and/or not verified if a study halted early so could well take data out of its context of disease population, dosage, other treatments and additional factors. Frankly worry giving “lawyers” such complete access would open door to (more) frivolous lawsuits as they data mine to “uncover clients” in a suit (of course could reintroduce Preemption protection for this circumstance).

  25. Mark
    June 8, 2009 at 5:01 pm

    Will there be an RSS feed for this blog?

  26. Max W
    June 8, 2009 at 5:23 pm

    I would echo some of what has already been said regarding ease of use for the average consumer and add the following:
    A fact sheet section describing the following would be helpful (1) FDA’s structure and how the FDA is related to (or not) to agencies such as HHS, NIH, USDA and CDC; (2) the FDA’s authority; and (3) various processes such as the FDA approval of drugs, biologics and medical devices. For example, until recently, I did not know that an IRB could be a private (for profit) company that is in the business of reviewing and approving federally-regulated products, such as drugs, biologics or medical devices.
    Also, the FDA website’s internal search engine is awkward. The hits seem to be in no particular order (e.g. chronological, reverse chronological or otherwise). In some cases when clicking on a search hyperlink you get redirected to an external website, such as the NIH, which may be geared towards medical professionals versus the general public. Often the titles of the searches are difficult to decipher. For example, I recently used the FDA website’s internal search engine and I got a hit titled “qbN-DY17”.
    Furthermore, when you use a search engine such as Google the FDA information, regarding the topic / issue, is often buried deep in the hits that are returned; and sometimes can only be found after combing through many pages.
    Finally the information in the website is often presented in a format that looks as though it came off a 1960s teletype machine (for example just clink on the Federal Register notice hyperlink above).
    I thank you for this opportunity and look forward to seeing this process evolve as well as what ultimately materializes.

  27. Daniel A. Casciano
    June 8, 2009 at 5:40 pm

    As a former FDA employee, I have some sympathy for the points Mr. Dickenson brings to the discussion regarding transparency. Granted there is a tendency within government (not just the FDA) to try and control the message, However, that is only part of the problem. Perhaps part of the problem has to do with the FDA culture that is directed to compliance which results in an us vs them attitude and a mistrust of not only the regulated industry but also the press. If you questioned FDA scientists, they will willingly respond to legitimate questions because they wish their work to not only be appreciated by other scientists but also the public that they serve. From my own experience, when reporters questioned me, I was always ready to truthfully respond to their questions. However, when I ask that I see what is written prior to publication, there is always reticence on the part of the press to comply which, in my opinion, sets up an antagonistic relationship.

  28. George
    June 9, 2009 at 3:00 pm

    So to start one would like a stronger definition of Transparency, and is it for the public or the industry (ies)?
    Where does Clear Concise easy to digest information fit in with transparency?
    As someone with no involment in any of the indutries other than being a consumer I’d like to see some of the following: How many inspections are performed on an annual basis. How many plants are there: How much food is inspected in total, and how much is rejected?( At present you can see amount rejected, but not the amount passed.) How much does the agencies depend on other agencies for inspections?
    Improving transparency is a way to build confidence, which would be welcomed, but at present we tend to hear about the agency’s failings not its successess.

  29. David L. Bergsma
    June 11, 2009 at 1:13 pm

    FDA is not updating its list of New Dietary Ingredient filings on a timely basis. In fact, the list has not been updated since 2001. New Dietary Ingredients are the life blood of the dietary supplement industry and such filings represent an important harbinger of the future of the industry, are critical to its planning and new investment and perhaps most importantly tell us how the FDA and the industry are doing relative to this important regulatory process.
    I am hopeful someone at FDA with knowledge of this matter or anyone else for that matter may choose to respond to this posting and also get the information updated as soon as possible.

  30. June 11, 2009 at 1:14 pm

    I applaud the move towards transparency. Speaking of which, can anyone at the FDA explain why 5 warning letters issued on April 2, 2009 are no longer available on the FDA web site? See my Pharma Marketing Blog post about this here: http://tinyurl.com/lo8lbd
    If there was an error in issuing these letters, the transparent thing to do would not be to simply expunge the letters from the site and from the listing of letters issued in 2009, but to keep a reference to the letters with a notation of why they were withdrawn, removed or whatever.
    Because they simply disappeared, we are left feeling that something undisclosed is going on, which is not a good start for FDA’s transparency initiative! IMHO.

  31. June 21, 2009 at 6:54 am

    Such a wonderful post, I would be glad if there are more like this one. Regards!

  32. LuAnn C. Kowar
    June 22, 2009 at 8:15 pm

    Dear FDA Task Force for Transparency:
    I am encouraged that this new initiative is underway, and anticipate it will yield a better interaction between agriculture, industry, consumers, and government oversight — all equally responsible for producing food and products that are safe to use, and are relatively reliable to impact who and what the product is intended to impact, without untoward collateral damage to persons, animals, nor the environment. Indeed the FDA has a heavy responsibiltiy for citizen safety, but the more clear — understandable, efficacious, and part of the public record — the proceedings of the FDA become, the more the public will be able to engage in the process of creatively protecting consumers and the environment from harm of any sort, due not only to drugs, but food and supplement substances that carry drug-like properties, including the issue of hormones or hormone-altering substances fed to farm animals, with resultant impact upon both child and adult health when animal-products are consumed by people. However, now that the issue of oversight of animal husbandry is pretty well-established, and only the debate needs to be conducted with scientific integrity and transparency, not yet so for the issue of genetically-modified-organisms. GMOs, as they are referred-to by the biotech industry, involve a wide variety of genetic manipulations of plants, animals, and microbes, which, in turn, have endless permutations in how they might impact human, animal, and environmental health over the long-haul. Please set-up a specific sub-Taskforce to deal exclusively with genetically-modified-organisms, surveying the science, and setting-up cogent ground-rules for industry to interact with: 1) the larger scientific community (e.g., intellectual property does not trump health when it comes to insisting that companies make-public salient impact studies); 2) the lay audience — citizens whose lives will be impacted; 3) all regulatory bodies like the EPA which have co-jurisdiction over environmental degradation and efforts at preservation and/or restoration; and 4) the international community, which cannot be isolated, given the scope of a global food-supply, with ready movement of seeds, crops, and foods across international boundaries. Please focus keenly and intelligently upon GMOs. Thank you.

  33. June 30, 2009 at 8:31 am

    It looks really great blog and it is nice to hear that our government cares about to find chanels to communicate with people . anyhow just wishing you good luck

  34. July 6, 2009 at 3:36 am

    It’s great blog and it’s nice goverment blog.
    I like your blog.

  35. July 18, 2009 at 1:27 pm

    Hello, to congratulate to the blog on his your initiative and to wish luck him.
    To ask if there are included topics of animal well-being, since he receives increasingly importance for the consumer, who at the moment of valuing the quality of a food concentrates not only on aspects as the information of the labelling but also on the degree of well-being of the animals from which ithe,comes. This is like that since one has started integrating(repaying) the animal(rude) well-being in the chain of food quality, which he has supposed that the interest of the consumers towards this point of the food production is increasingly increasing.
    Thank you and a greeting.

  36. SEO
    July 20, 2009 at 5:29 pm

    I agree with Lorrie Hellier the FDA is a science-based agency first.

  37. July 31, 2009 at 6:54 pm

    Well, what i think is that the FDA needs to return to its roots as our consumer protection agency for ensuring that medications, medical devices, and food are approved for safe consumption by the public.

  38. July 31, 2009 at 6:57 pm

    I feel optimistic that this blog exists and that the FDA is moving towards a more open and transparent existence. It may not be easy, but is definitely a challenge worth taking.

  39. July 31, 2009 at 7:00 pm

    The first is heavily dependent on inspections and ‘being there’ while the second requires a rare brain trust. The prior commissioner was a proponent of the second while not putting resources into the former (hence the problems due to lack of inspections and enforcement of GMP).

  40. pentassoft
    August 14, 2009 at 12:13 am

    FDA move ahead with this blog….
    good achievement

  41. acai berry
    September 21, 2009 at 10:38 pm

    I just wanted to personally thank the fda for being so transparent in setting up this blog! It really shows that the fda is on top of things always and open to public opinion.
    Acai

  42. gttle
    September 29, 2009 at 2:45 am

    That great for launching this blog.

  43. Samuel
    November 2, 2009 at 12:14 am

    This is a great blog with adequate information for the visitors. Hope FDA will move ahead with this attempt

  44. greenwave
    November 2, 2009 at 2:46 am

    well I hope this blog will make easier for citizen to get information that needed. Especially about new drug release

  45. Juan Batista
    November 20, 2009 at 9:20 am

    I have always felt that the FDA was a necessary, and great part of society’s protection. The importance of monitoring and restricting possible threats to health is of paramount concern. I believe that, as a nation, we would and could have suffered great loss without all your efforts. For this, I can say only the best of things for your diligence. Keep up the exceptional work.

  46. Web 2 Mayhem Review
    November 22, 2009 at 3:31 pm

    Thanks for a really informative blog. I’ll be back to read more later tonight.

  47. Au Pairs
    November 25, 2009 at 7:05 pm

    Any and every type of transparency from the FDA blog will be great. I look forward to reading some in depth information.
    Thanks for starting this.

  48. Emergency Dental
    December 5, 2009 at 12:14 am

    I am excited at the notion of the FDA letting the public know their initiatives. Hopefully the FDA will improve its reputation as a protective agency to ensure medication and food that we consume are determined to be safe.

  49. Colon Cleanse
    December 12, 2009 at 3:29 am

    This is a great blog with adequate information for the visitors. Hope FDA will move ahead with this attempt

  50. Agricultural ATVs
    December 26, 2009 at 11:25 pm

    I agree with Melody Hoadley – whilst t is great to have a complete transparency policy, it would also be beneficial to see how this would work on previous approvals and the process!
    There is a lot to be said for transparency within governmental office – keep it going, the standards should then be followed.

  51. Dentist Thornhill
    December 30, 2009 at 10:03 pm

    Thanks for sharing this topic on FDA transparency. Opening the FDA agency’s doors and windows can do a lot to dissolve the perception that it has become a corporate structure, rather than a guardian of the American people.

  52. Jaromir
    January 7, 2010 at 2:15 pm

    Hi
    Every government should take care about people comments….
    Hope FDA will move ahead with this attempt

  53. Kim Shawn
    January 13, 2010 at 5:11 am

    Good information. Finally FDA would be efficient and be able to cut out all the delays.

  54. Loose Fat Stomach
    January 15, 2010 at 6:03 am

    FDA is so humble.
    Great information.
    We should respect FDA for they are truly performing their jobs for mankind.
    I salute you, FDA.

  55. Personals
    January 16, 2010 at 7:40 am

    i love reading this article, this is very informative and amazing! thanks for posting this info,

  56. David Young
    January 17, 2010 at 4:30 pm

    How nice would that be if not just the FDA but all our governments agencies would adopt policies to make their actions more transparent and accessible to the people. Thanks

  57. children dentist
    January 18, 2010 at 12:48 am

    It has definitely been clear that a diverse constituency is dissatisfied with the state of FDA’s transparency, and has been for a very long time. While I share all of the concerns, my own ongoing concern is the inhibition of FDA employees generally when it comes to freely giving their ideas and opinions to the news media.

  58. Kris
    January 21, 2010 at 6:00 pm

    The more I read of the FDA of late, the more impressed I am. They have a very tough job and are performing brilliantly
    Keep up the good work guys!

  59. kris
    January 22, 2010 at 11:48 am

    I think the FDA is really moving in the right direction. These sort of changes keep making a more efficient and relevant organisation

  60. Free iPhone 3GS
    February 2, 2010 at 3:41 pm

    great post thanks for sharing!

  61. Free iPhone
    February 2, 2010 at 4:51 pm

    The FDA is a great service keep up the amazing work. thanks for sharing this post about eh fda.

  62. Adam Ryan
    February 2, 2010 at 5:27 pm

    Thanks for FDA and its transparent moves. Not only americans but all the world need such great communication between government and people. Thanks to freedom.

  63. CLICK Paid Search
    February 2, 2010 at 5:45 pm

    This FDA Transparency blog is easy to navigate, and is a step towards eliminating the barriers between communication with online people. A blog design recommendation would be to increase the length of your search text box.

  64. Business Loans
    February 3, 2010 at 3:47 am

    FDA Transparency is definitely needed or else we will have another American auto industry situation on my hands.

  65. Tezgah
    February 9, 2010 at 3:50 pm

    Transparency to the American public is a fine goal and I applaud your efforts to do this in an online forum. However, the industries you regulate need the FDA to be transparent as well. The American public has to know what is going on behind the close doors.I also thing that FDA has to use basic language that we people understand easily. Thank you

  66. Newark Rea Estate Blogger
    February 9, 2010 at 8:32 pm

    This initiative is great and I really appreciate the effort. A clarification of FDA’s relationship with other agencies such as HHS, NIH, and USDA will be great.

  67. Pariuri Sportive
    February 13, 2010 at 1:45 am

    FDA Transparency Blog looks like a very promising project, good luck with your work and keep us all informed on its progress and how its use has benefited small community groups.

  68. aleska
    February 13, 2010 at 4:50 pm

    It’s great blog and it’s nice goverment blog.
    I like your blog.

  69. aya
    February 15, 2010 at 9:53 am

    As a FDA employee, I applaud the intent of this blog. http://neolist.in

  70. web hosting reviews
    February 15, 2010 at 10:02 am

    Thank you so much for pointing it out. It’s really very great that FDA communicate with puplic through this valuable blog. thanks..

  71. vanzari auto
    February 16, 2010 at 10:42 am

    These barriers between government and citizen I do not think that will be eliminated. But I believe strongly that relations will improve over time if those people will change corrupt the system. They make us bitter and because their life has stalled things.

  72. powerrc
    February 28, 2010 at 4:50 pm

    It is so refreshing to see such an initiative within the states. Here in the UK we have had much trouble as a result of being translucent. With our elections approaching we are hearing much talk about transparency – it would be good to see the successful party put this theoretical policy in to practise. I will point my local Member of Parliament in the direction of this weblog.

  73. MMA pound for pound
    March 3, 2010 at 2:47 pm

    That’s nice to read you blog as you continually provide great contents not seen on other site. Keep it up your site visitors will love your site a lot.

  74. Romertopf
    March 10, 2010 at 2:14 am

    Thank you for posting this blog. Any transparency initiatives are always a good thing, in my opinion. It’s also good to see so many people involved in posting. The only thing I would say is that I had no idea the FDA had a open blog prior to visiting the FDA site, but it is good to see from other posts that the word is getting out.
    It seems like the FDA is really trying to meet the needs of American citizens. I think the FDA has been doing a good job in recent years.

  75. March 15, 2010 at 2:40 pm

    I would be glad if there are more like this one. Regards

  76. Daniel
    May 8, 2010 at 1:06 am

    I totally agree with Daniel A. Casciano on the above post The FDA Needs to make there information more user, or people friendly instead of making it like reading code..

  77. Axel
    May 9, 2010 at 4:06 pm

    Thanks for posting this info. FDA Transparency is definitely needed!
    http://einkochautomat.net

  78. Bruce Reitman
    May 11, 2010 at 9:18 pm

    I think this is great that you want to hear from the general public. One thing I believe the United States is behind in is, making amalgam fillings illegal in this country. There is evidence of many being hurt by mercury poisoning. I think we need to follow other countries who already have made this substance illegal.

  79. Peter Steele
    June 1, 2010 at 1:21 pm

    I think this is a great initiative. As a current student enrolled in pharmacy school, I am excited to see where the future is heading.
    One of the challenges I see are actually reaching out and letting the public know about your initiatives. I only knew about this because my preceptor e-mailed me about the conference call yesterday. Any help with this, please let me know.
    Thanks again for your efforts!

  80. kullanıcı
    June 25, 2010 at 6:32 am

    dizi izle, online dizi,dizi keyfi,canlidizi,ezel dizisi izle, dizisi izle, kurtlar vadisi dizisi izle.
    Thank you for launching this blog. I have sent correspondence to Ashley Boam, Chief, Interventional Cardiology Devices Branch, asking for more transparency and inclusion of patient voice in the development of medical device trials, particularly related to PFO/Migraine research. I appreciate Commissioner Hamburg tackling this issue. The effort to include comments from the public in this discussion is a pleasant and exciting change.

  81. Telephone Answering Service
    July 6, 2010 at 1:18 am

    I think this is a great initiative. I am so excited to see where the future is heading.
    Thanks for creating this beautiful article.

  82. Kansas City Web Developer
    July 6, 2010 at 11:47 am

    Really truly I’d feel safer if the FDA split in two. The people who feed us medicine should not also control what we eat. Two very separate things. Just my opinion, thanks~

  83. professional seo
    July 9, 2010 at 8:32 am

    Without that, FDA’s been left alone too long pursuing its own goals and now can’t find its way home.
    Who will lead FDA back home? The transparancy police?

  84. July 16, 2010 at 3:35 am

    well for me FDA play big role in food and drugs industry they are the watch dog for us consumer and protect us from those malicious vendors who is after for the money only
    Transcription Work

  85. Hostess firenze
    July 23, 2010 at 6:28 am

    FDA Administration is committed to eliminating the barriers between the American people and their government, and the Task Force is another big step in the right direction.The FDA is responsible for protecting the food we eat and the medicine we use — its work impacts every American, and ensuring the agency is open and accountable to the American people is critical, Thanks.

  86. San Diego Real Estate Agent
    July 25, 2010 at 3:32 am

    I would be interested in the response to the question of just what role is / should the FDA be playing?
    I don’t know if there is another department responsible, but why is it that our Western medicine focuses so heavily on drugs as the solution and so little on preventive actions?

  87. maps4pets
    July 25, 2010 at 7:48 am

    How would this effect the pet industry please? Is there an overlap of any sort. The reason is that we work with a great number of charities etc within the pet industry and it may be good to know.

  88. Health Articles
    July 25, 2010 at 12:17 pm

    The FDA needs to be more open with the food and drugs policies. This blog is a good idea and if it makes policies more open then lets hope the world is a better place!

  89. Voice Over Guy
    July 25, 2010 at 5:16 pm

    Excellent! If course, transparency efforts like these fly under the radar of most Americans. The Fox News audience will never hear about how the Obama Administration followed through on this promise. If I could recommend anything, it would be that you actively court the public’s interaction here. That will accomplish two goals: highlighting Obama’s follow-through and also allow the FDA to measure it’s effectiveness working for The People.

  90. Tony | rent a car guy
    July 26, 2010 at 12:12 am

    “Providing information to the public in a user-friendly and timely manner is critically important to the work of the agency and its credibility with the public.”
    It is also in the tradition of American Democracy and I value that you pay so much attention to Transparency to the American public.

  91. Anne Ahira
    July 26, 2010 at 10:36 am

    I like what Mike explained about the “three priorities”!
    By the way, where is the RSS feed??

  92. Nail technician courses
    July 26, 2010 at 1:14 pm

    I think this is a great initiative. Is interesting to see where the future is heading.

  93. Renato and how to watch free online movies
    July 26, 2010 at 5:27 pm

    This decision by FDA is welcome.Hope it,as pointed by secretary of HHS ,will eliminate the barriers between the government and people.

  94. ed cullom
    July 26, 2010 at 9:48 pm

    I feel it is ggod the FDA is trying to bring things in line as far as the safety factor goes, but just because it does not kill us right away does not mean it will not do some harm down the road. Alot of what is being put in our foods are things that will do damage down the road, but they increase profits now.

  95. Kevin
    July 26, 2010 at 11:34 pm

    I commend you on starting this blog.
    Our Government is based on transparency and in matters affecting the well being of so many Americans such as those under the FDA, making the information accessible to as many citizens as possible and delivering it to them as fast as possible is critical.
    What better way than a blog and social media.
    Keep up the good work.

  96. Trevor Seo
    July 27, 2010 at 12:56 am

    I suggest that FDA posts updated status of existing FDA EXAM/DETAIN entries and make available for importers to check themselves other than relying on the FDA Status Hotline.
    I suggest FDA provide importers an easy and convenient method of contacting FDA to request for re-evaluation on certain entries when a medical device is being labelled “FDA EXAM” while the same device is already being examed by FDA in the same month.

  97. July 27, 2010 at 2:01 am

    “As a retired FDA employee, I applaud the intent of this blog. It is refreshing to see an administration that is supportive of science because the FDA is a science-based agency and cannot realistically function if the political appointees abhor science. I think that one consideration of the new FDA administration is to find a simple mechanism of communicating with the public and to do this in plain language. This requires overcoming the FDA culture that is directed toward compliance and not explanation. I suspect that most citizens receive their information about the agency via Lou Dobbs, who doesn’t understand government much less the mission of this regulatory agency. In my opinion, neither the FDA Consumer nor the web site fulfills the needed communication link to the public. The FDA’s mission to promote and protect the public health will be more complicated with the additional responsibility to regulate tobacco industry,”
    I do agree with you however I think the FDA should go all out in making an open database of information regarding their regulations on the internet. The entire public should have access to it, just like laminate flooring. Thats just my opinion though…

  98. Afia Asamoah, Transparency Intiaitive Coordinator
    July 27, 2010 at 9:12 am

    The RSS feed can be found in the right hand column of the Transparency Blog main page. The link is http://fdatransparencyblog.fda.gov/atom.xml

  99. ed cullom the patent guy
    July 27, 2010 at 12:24 pm

    What does the fda have planned as far as to the ingredients that are being placed in childrens drinks and foods at school.

  100. David Dunham
    July 27, 2010 at 12:28 pm

    Does this mean that the FDA will be making more concerted efforts into investigating the relationship between, albeit a small percentage of government empowered officials and major Pharmaceutical Companies? This would certainly be a step in the right direction for improving public esteem of the FDA.

  101. George Diakos
    July 27, 2010 at 6:34 pm

    I am excited that the FDA and other arms of the government are creating blogs and interacting with citizens. It can’t do anything but help and hopefully many of the suggestions will help form future policies.
    Great job for being “forward thinking”!
    Cheers,
    -George D

  102. john
    July 27, 2010 at 10:53 pm

    Well done to the FDA. Transparency is crucial to public trust and this means that you are taking a step in the right direction.

  103. Geoff
    July 28, 2010 at 2:36 pm

    Its great to see that the American government listens to its people and allows them to participate in places such as the FDA where any mistake made in registering a medicine could cause untold misery to people if the FDA should make a mistake.

  104. Mario, a Quebecer
    July 28, 2010 at 3:46 pm

    Hope this initiative is better than the one we have in Canada. Listeriose crisis is an example.

  105. Giselle Brand, Dietitian
    July 28, 2010 at 10:51 pm

    We are looking at a worsening health care crisis if we continue the way we are, prescribing drugs to an ever aging population with more and more chronic diseases. It is deeply concerning when I see government programs here in Australia spending millions of dollars on prevent-diabetes programs and getting virtually no referrals to these programs from doctors.
    This is because most doctors are so busy prescribing medication for existing ailments that no time is left for considering preventive care and lifestyle changes.
    There simply is much more money to be made in prescribing drugs than in helping patients prevent serious diseases.
    That is why we need decisive government action – we cannot rely on private enterprise.

  106. 30
    July 29, 2010 at 7:01 pm

    Even today the FDA still has a tough job ahead of itself. It has to provide safeguards for society against crude forms of food and drug adulteration still.

  107. Pharmacist Society
    July 30, 2010 at 4:04 pm

    Social media is not a fad and here to stay. I would like to see the FDA use social media more as an outlet to provide the public with information.

  108. Scotty's Free Coupons
    July 31, 2010 at 2:01 pm

    I appreciate your efforts to make the agency more open, but there is so much to be done. In fact, the U.S. Patent and Trademark Office releases far more drug-related information than the FDA currently does, which is an indication of just how much this agency really needs to change.

  109. Marc
    July 31, 2010 at 5:47 pm

    It would be nice if we could have a website to go to to find out about changes to FDA policy and new drugs that have been approved. This type of information is needed by many people who are waiting for new treatment options.

  110. Don (Industrial Training)
    July 31, 2010 at 9:26 pm

    I agree with some previous post; FDA needs to communicate more with consumer. Maybe some new, innovative ways. Like Consumer Advocate news breaks on TV (Playlist of them on Youtube.)

  111. August 1, 2010 at 9:20 am

    I’d like to see better regulations on produce farmers. The abuse that seems to run rampant throughout these industries is appalling, and unnecessary. I love meat, but that doesn’t mean that I want my food to be tortured before it arrives on my plate.
    Also, I’d like to see what hormones and other chemicals are being introduced in my food, what the FDA is allowing the food industry to add to our food that’s potentially making antibiotics less effective when the American public really needs them to fight off infections. If we’re going for transparency, there should be mandatory labels on our food about this, just as there is about the fat and sugar content.

  112. 50 Plus Sam
    August 3, 2010 at 4:23 am

    The FDA has the undisputed authority on food and medicine, but it as also important to have alternative medicine monitored under the existing charlatanism in this field.

  113. M Jones
    August 3, 2010 at 4:46 am

    This is a big job for FDA employees and the organization as a whole. It needs tools and resources, and this blog is one of them for the public to comment. Everyone has great expectations for changes and better functioning government.

  114. Scott the CNC Milling man
    August 3, 2010 at 7:08 am

    Transparency is always a good thing for the public

  115. 90 workout
    August 4, 2010 at 2:36 am

    At times potential benefits to patients appear to “get lost” in a overly stringent statistical dogma because those outcomes do not fit in to standards for objective criteria/interpretations.

  116. Scott
    August 5, 2010 at 2:41 am

    We are experiencing all sorts of problems with our government here in the UK…the public cried out for transparency and literally heads kept rolling until we got it

  117. August 7, 2010 at 10:21 pm

    I am liking your blog. Good to see the embracing of technology so we can all keep up.

  118. Andrew
    August 10, 2010 at 11:27 pm

    I live in Australia and I only hope that soon our equivalent of the FDA sets up a blog like thios and lets us know what’s going on in this coumntry with our food and assitives etc. I know that there’s a lot of chemicals that are banned in the US but are still widely used here and we can get no explanation as to why this is the case. The Food Safety information Council is OK but I think they are not telling us the whole truth about a lot of what goes into our foods.

  119. Brent the http://biginternetmarketingtools.com
    August 11, 2010 at 5:57 pm

    We have been hearing about a new transparent Gov for some time now. When will it happen in all the areas of the administration?
    It’s very good the FDA is doing it and all the rest should too.

  120. Elder Care
    August 13, 2010 at 1:23 pm

    It’s nice to see that there are changes in place and that perhaps now the FDA can get back to being an efficiently run department without all of the delays, holdups, secrecy, etc. surrounding the decisions and management choices made.
    I second that!

  121. eCig
    August 14, 2010 at 4:59 am

    It is good to have some direct communication channels between people and government. Good work.

  122. thomas
    August 15, 2010 at 3:06 am

    Congratulations for the blog
    10x for all the hard work

  123. Paul the tinnitus guy
    August 17, 2010 at 10:39 pm

    I have to give the FDA respect for providing this blog and trying to create an open relationship between the government and the people. Great to see it in action and please continue the good work.

  124. akron dental
    August 18, 2010 at 11:27 pm

    yes the FDA has a very important role and it’s nice to know they’re working towards what is better for the american people.

  125. Ford Michael
    August 19, 2010 at 8:36 am

    I am little bit confuse about the FDA, because its recent negative movement and failure are much more obvious than its success. Transparency to the American public is a fine goal. I am thinking about that tools used for research to amine drugs, foods, and regulatory actions are already available in the depths of the FDA website. They do only one thing is it’s easy to use.
    And last, we all need to look forward.

  126. steve beaton
    August 21, 2010 at 10:59 pm

    The FDA clearly has it critics (I guess I’ve been one), but sincere efforts towards true transparency have to be applauded. It’s easy to point to corporate tendencies and doubt the commitment to the protection of the American people, but throwing open the agency’s doors would go a long way towards dispelling this damaging perception. If the FDA want to secure settled and long-term funding, a renovation of its public images is surely an essential and long overdue step.

  127. Skipta
    August 23, 2010 at 1:41 pm

    The best way I think to improve transparency would be to launch a social media campaign. I would use outlets such as Twitter, Facebook, and Skipta to get the message out.

  128. Dave of Ayurvedic Remedies
    August 30, 2010 at 12:15 pm

    The transparency policy is a very welcomed addition for the public for which it is supposed to protect. For it is only through openness such as this very blog that all of us in the USA can feel free to agree or disagree; to express our opinions without fear.
    There are still many countries in this ‘Modern’ world of ours where the citizens are excluded from the dialogue at best and in some cases are even prosecuted for having an opinion of their own.
    I am still hopeful that the day the FDA opens itself up to studying alternative, non-toxic, non-invasive medicines, is not far away.
    May this trend spread to other governmental agencies in the US.
    Bravo FDA – Way to go!

  129. Tom the Strip That Fat Guy
    September 6, 2010 at 3:48 pm

    The FDA must get back to doing the job that it has superbly done for decades. It must oversee drug companies that are hitting the public with bad drug after bad drug that has to be pulled from the shelves every day.

  130. Mike
    September 6, 2010 at 4:05 pm

    Transparency is a noble goal. The question I have is the real will there to be transparent. With transparency one must be willing to live with open discussion and criticism. Like one of the original comments says, the FDA has lost it’s way. This could be the new beginning required in so many places within government. If there is the will to hear from the real people and not just the large corporation when making decisions. Kudo’s to you.

  131. william - como recuperar a tu ex
    September 9, 2010 at 4:05 am

    A controversy now exists where insulin producers—seeking to prevent generic production/competition—have testified before Congress that THEIR biotech drug(s) are comprised of such complicated proprietary information that NO generic manufacturer can perfectly and safely duplicate their product in a generic version

  132. Smith Mountain Lake Blog Girl
    September 9, 2010 at 12:21 pm

    What is the FDA’s position on BPA’s in drinking water, and do you think that it is safe for all new construction homes to employ CPVC and PEX in our homes?

  133. DB Pearl
    September 10, 2010 at 6:20 pm

    Pretty interesting. It feels so amazing to have read an article full of good insights. I would be sure coming back to your site to check on your new updates then.

  134. Mark
    September 13, 2010 at 3:01 am

    This would be a nice beginning for every bloggers. Thanks
    googlesandroids

  135. Ginekologijos Klinikos
    September 16, 2010 at 3:57 am

    It’s nice to see some changes starts to emerge.
    People must know what desicions are made and most important – WHY they are made.
    More honestly it is said, more likely people ar willing to accept it.

  136. charlotte
    September 17, 2010 at 5:58 am

    I must be grateful for the launch of this blog. I have learned a lot from here.

  137. September 19, 2010 at 7:40 pm

    As a farmer and grower of grain seed, I feel it’s imperative for the FDA to be transparent in all that it does. Doing so will continue to build trust in a vital Government Agency.

  138. September 21, 2010 at 3:43 am

    Dear Kathleen and Margaret,
    I think this exercise of manifesting greater transparency on part of the FDA is certainly a laudable effort, and I hope that people learn to appreciate the time and effort it takes to maintain such an ongoing stream of information. I especially appreciate the fact that you are making a sincere attempt to not only inform people of the changes and new policies, but also why these changes are being made.
    I am particularly interested in more details of what stand the FDA is taking / planning to take with regards to genetically modified crops, etc., and how you plan to address the falling out of Monsanto’s GM crop policies that are affecting farmer suicides in places like India. Would it be possible to address this in your blog?
    I also agree with Justin (please see post above), in that we need to be informed as to what types of hormones, enzymes, etc. are being added to the food we are consuming. As people looking to the future, we want to certainly be somewhat in control of what goes into our bodies, and into the bodies of our children.
    Again, I commend you on this effort, and wish you all the best in your endeavors.

  139. September 21, 2010 at 10:34 am

    I think over the years there has been huge barriers between the American people and the Goverment. Its nice to see that changes are now happening which is certainly a step in the right direction.

  140. September 22, 2010 at 12:22 am

    Appreciate the proposed between people and government, it is a positive move.

  141. September 22, 2010 at 10:21 pm

    This is a huge job for FDA employees and the organization. However, we must appreciate the fact that just the load of information at any given time, despite being huge, is handled in a very professional and efficient way. It is a highly commendable effort that deserves praise and assistance in any way possible. The FDA will face many challenges in the future, as food technlogies advance and we rely more on genetically modified crops to survive. I have to agree also with the post from George Diakos above that everyone needs to be commended on the forward thinking that we are experiencing. I wish all the best!

  142. September 23, 2010 at 9:27 pm

    There is always a compromise between safety and being over-regulated and the associated costs that go with that. We have to trust that the people we put into these positions of implementing policy are well informed and not influenced too much by budget constraints.

  143. September 25, 2010 at 12:23 am

    The content is definitely stellar… You know how to balance writing and opinion. However, I cant get over how little you actually bring to light here. I think that everyones said the same thing that youve said over and over again. Dont you think its time for something newer, especially for a college site…?

  144. September 26, 2010 at 4:29 am

    The more transparency the better. We can also cast our vote by the food we choose to buy. It’s more likely that local produce is safer than produce that’s come from the other side of the world. And let’s all try to keep healthy so we don’t have to take many drugs!

  145. September 26, 2010 at 10:57 pm

    I am happy that efforts are being made to make the FDA more open and transparent to the public. The people of America need to feel more connected with what is going on with the government.

  146. September 28, 2010 at 12:09 am

    FDA is tasked to regulate products ensuring the safety of the American public and the effectiveness of marketed food, medical, and cosmetic products. This transparency blog created by FDA was built for informational purposes where issues can be discussed and a good way to warn public about purchasing certain products.

  147. September 28, 2010 at 11:55 pm

    The sheer volume of comments indicate that approval of the FDA efforts, keep up the good work.

  148. September 29, 2010 at 4:41 pm

    Transparency in all government departments should be the goal of all governments around the world. Hiding behind secrecy rules and claiming it is keeping things hidden for the good of the public is not good enough. Governments tend to believe we are incapable of understanding what they do. The reality is most of them have never worked in the “real” world and would not last five minutes out here.

  149. October 6, 2010 at 2:53 pm

    I’m glad to see more transparency at the FDA. I too believe this should be a primary goal of all government agencies.

  150. October 6, 2010 at 7:19 pm

    I hope the FDA will start using stonger regulations on medications. There are just too many drugs that harm or kill our american citizens.

    Jason

  151. October 8, 2010 at 12:13 am

    Searching google I found this blog and thank you for spending time on a blog to the issues that are of our interest like the food we eat.

    I really appreciate the effort because I know that takes time to blog

    Best Regards.

    Damian

  152. October 9, 2010 at 12:44 am

    Why don’t all our governments agencies would adopt policies to make their actions more transparent and accessible to the people.

  153. October 9, 2010 at 12:45 am

    Why don’t all our governments agencies adopt policies to make their actions more transparent and accessible to the people.

  154. October 17, 2010 at 1:41 am

    Wow, a government agency actually talking to the people, whats next?

  155. October 17, 2010 at 8:32 pm

    Wow, Nice blog, Can I know what theme did you use ?

    • afia29
      October 18, 2010 at 2:35 pm

      The theme is called “Inove” with custom css applied.

      • July 1, 2011 at 7:20 pm

        Thank you for this information. i am looking for a similar theme

  156. October 17, 2010 at 8:34 pm

    Wow, Nice blog, Can I know what theme did you use ?

  157. October 27, 2010 at 9:25 am

    Being a nurse I know the importance of this topic, so well done people for this blog.

  158. October 29, 2010 at 12:05 am

    Very informative post! Regards!

    -Chin

  159. November 4, 2010 at 9:45 am

    Transparency is a good thing because it can help lessen corruption. All we can hope that the committee is unbiased and true to its word.

  160. November 9, 2010 at 1:17 am

    Its a forward step that this blog demonstrates that the FDA is moving towards a more open and transparent existence.

  161. November 17, 2010 at 6:09 am

    yes agree to that transparency can really lessen corruption. Wondering why the Philippines is claiming total transparency..hmmmm…

  162. November 23, 2010 at 5:08 pm

    It is such a great thing to know that the government is embracing the idea of “transparency,” and increasing the amount of real information available to those of us most affected by government actions, especially in agencies such as the FDA.

  163. World Of Warcraft Blueprint And Guide
    December 12, 2010 at 5:10 am

    Thanks for the great post. I will tell my friends about your page. Thanks again…

  164. December 13, 2010 at 8:47 am

    It’s a good job between American people and American government.

  165. December 22, 2010 at 3:21 pm

    The FDA has too much authority on food and meds, they stand to take away our health freedom

  166. January 6, 2011 at 11:50 am

    I think this is a great initiative.Thanks for the great post. I will tell my friends about your page.
    Very informative post.

  167. January 6, 2011 at 2:53 pm

    It’s nice to have some direct communication channels between the people and government. I think that in recent years has been enormous barriers between the American people and the Government.

    Best regards

  168. January 6, 2011 at 9:43 pm

    I think it is a great start. I hope that transparency continues throughout the rest of government and does not just stay here.

  169. January 10, 2011 at 4:34 am

    I think this is a great initiative..Thanks for the great post. I will tell my friends about your page.
    Thanks again…

  170. January 10, 2011 at 12:52 pm

    Congrats for the goo job!!Regards!!!

  171. January 10, 2011 at 8:27 pm

    very good success in content and design62

  172. January 10, 2011 at 8:27 pm

    very good success in content and design63

  173. January 11, 2011 at 3:31 am

    This FDA decision welcome.Hope, as outlined by the Secretary of HHS, will eliminate the barriers between people govt.

  174. January 11, 2011 at 4:10 am

    Journalists are invited to submit questions to the FDA Media Office through their normal channels and to refrain from submitting questions here as comments. Reporter questions will not be published.

  175. January 28, 2011 at 10:17 am

    That is my initial time i visit here. I discovered a lot of entertaining stuff inside your blog, particularly its discussion. From your a great deal of comments in your articles, I suppose I am not the only one having all of the enjoyment here! Maintain up the good work.

  176. January 28, 2011 at 2:50 pm

    A good article. I read a very impressive. I like the articles you write. Will follow up your writing so on. Thank you very much.

  177. January 29, 2011 at 11:51 pm

    This looks like it’s getting somewhere, I hope it really does…

  178. February 3, 2011 at 12:10 pm

    Thank you to everyone is a useful subject13

  179. February 14, 2011 at 9:12 am

    Many thank this is good article.

  180. February 18, 2011 at 3:37 am

    Transparency will surely help FDA do away with complexities between the the American people and their government. I am certain the Task Force will produce positive results in these aspects. I am looking forward for great news and more of these blogs!

  181. February 21, 2011 at 4:28 pm

    the truth that is good to see that the Old Testament of the U.S. government want to adopt a technological transparency.

    Transparency for the American public is good and I appreciate their efforts to do this.

    I commend the blog and I think a very successful initiative.

    A hug.

    Jimmy

  182. March 12, 2011 at 11:04 pm

    thank this is good article.

  183. March 19, 2011 at 10:10 am

    Thanks for this very informative post. This is great.

  184. March 20, 2011 at 12:13 pm

    I have to show some thanks to the writer just for bailing me out of this type of scenario. Right after exploring through the online world and obtaining methods which were not helpful, I believed my life was well over. Living without the presence of solutions to the issues you have sorted out as a result of your main review is a serious case, as well as the ones that would have adversely affected my career if I hadn’t encountered your blog. Your training and kindness in dealing with all the stuff was very useful. I don’t know what I would have done if I had not discovered such a step like this. It’s possible to at this point look ahead to my future. Thanks a lot so much for your skilled and result oriented guide. I will not hesitate to endorse the website to any individual who would like direction on this matter. btw this is my website about Low Self Esteem Symptoms

  185. March 25, 2011 at 5:04 pm

    I appreciate that the FDA has a forum for user comment.Thank you for the information.

  186. April 8, 2011 at 8:01 pm

    The FDA does some times have some lackluster procedures for manufactures to display on their products but there is such a flow of new products at play at all times it is really difficult to control this rush on information

  187. May 14, 2011 at 6:17 am

    FDA has used administrative and insurance claims databases to investigate safety questions about Agency-regulated products, but generally it has only worked with one particular healthcare system at a time to evaluate a given safety issue. Its goal now is to create a linked, sustainable system.

  188. May 27, 2011 at 9:12 am

    This post is fascinating! FDA really rocks!

  189. May 30, 2011 at 7:22 am

    We are very much tense for our health. We are Bangladeshi but here not have any organization like FDA. Our medicine and food poisoning transparency is very much poor. We hope Our Government will build up a organization like FDA.

    Thanks all.

  190. May 30, 2011 at 2:50 pm

    Lets hope this will eliminate the barriers between the govt and the people.
    This open forum is a great first step to transparency and
    I hope that this transparency continues throughout to the rest of government departments.

  191. June 27, 2011 at 1:42 pm

    I’m glad to see this blog has been launched, transparency is the key to gaining the trust of the people. As a person with acute allergies, it’s nice to see what is going on behind the scenes (what used to be behind the scenes).

  192. June 30, 2011 at 5:31 pm

    The FDA is going to have a tough time trying to keep up with everyone trying to make at buck at the expense of the health of our country.

  193. July 2, 2011 at 3:16 am

    Thanks for this great post, really interesting and informative.

  194. July 7, 2011 at 11:06 pm

    I will be spreading the word about this post. I really liked it!

  195. July 10, 2011 at 2:32 am

    By using this forum, the FDA is opening themselves to the larger mind. This is a true mastermind and we can hope if the few listen to the many we will all benefit. Good on them for launching this.

  196. July 13, 2011 at 3:18 am

    This is definitely a must considering all the recent food issues that we’ve been having lately, well at least where I live.. Now we’ll be able to discuss in closer contact the kind of things we’d like to see change and how certain standards affect the kind nutrition we have. I’ll definitely be sticking around here.

  197. July 14, 2011 at 4:34 pm

    Many thank this is good article.

    Best regards.

  198. July 14, 2011 at 6:18 pm

    This is a great post! Thank you so much for sharing this information.

  199. July 18, 2011 at 3:29 pm

    Thank you for this informative post! Great blog with lots of information. Thanks for all. Regards

  200. July 19, 2011 at 3:37 pm

    Great job guys,
    Getting all this info out to the general public is way overdue. More people need to be made aware of these important issues that affect us all, keep it coming.

  201. July 24, 2011 at 8:57 pm

    I’m glad there are steps being taken toward transparency… of course there are more steps and more progress to be made. The key to it all is the progress element. Keep Going forward!

  202. July 25, 2011 at 2:30 am

    Thank you so much for sharing this valuable information.

  203. July 28, 2011 at 9:09 am

    Thank you for this post. I strongly support this initiative, and most of the comments and suggestions that have been made on the Weblog to this point (I have read them all). It is clear that a diverse constituency is dissatisfied with the state of FDA’s transparency, and has been for a very long time.

  204. July 28, 2011 at 10:42 am

    The FDA should be there to look after the interests of the public at large, not vested interests; as should any goverment agency. Terrific blog.

  205. July 29, 2011 at 11:48 am

    It’s nice to have some direct communication channels between the people and government.

    Thanks

  206. July 29, 2011 at 11:53 am

    I’m glad to see this blog has been launched, transparency is the key to gaining the trust of the people. Thank you so much for sharing this

  207. Why Stop Smoking Weed
    August 2, 2011 at 11:30 pm

    Transparency leads to credibility. You are doing a good job to increase credibility in American Institutions. Is a hard job to do, but it will pay up. Keep up!

  208. August 8, 2011 at 11:17 am

    This is quality move by FDA to make everything transparent and also listen to people view on matters that affect them. I really like how easy the blog looks because it makes it easy to navigate and find things.

    Larry

  209. August 10, 2011 at 4:21 pm

    I am in the elder care field and while I agree this site is a wonderful step in the right direction, I would like to see more information on how PHarma and the manufacturers interact with the Medicare program to create such a complicated and dysfunctional system. Even as I write this changes are being made but many, many seniors are still in a no win situation choosing between bad and worse. In many cases it isn’t your money or your life. PHarma seems to want their money and their life. Please do more to expose the relationships between the government and private pharmaceutical companies to help me explain to elders why their meds are so expensive and how their vote might possible make a difference. Thank you.

  210. August 11, 2011 at 1:06 pm

    that right. what you said is true i will ask to other people all about your idea.

  211. August 11, 2011 at 1:08 pm

    i agree what are you said. because your idea are brilliant and so clear to understand.

    • August 11, 2011 at 8:40 pm

      yes that good idea i think…

  212. August 13, 2011 at 6:53 am

    Thank you for making this Forum available to the public. This is definitely a step forward in providing more transparency between FDA and the public. I am wondering if questions are going to be answered right here or are you going to respond by email?

    Thanks!

  213. scottie
    August 16, 2011 at 6:25 am

    I sure wish that the FDA would look into some of the treatment claims being made by prostate supplement manufacturers and sellers on Amazon. “Is a Natural, Highly Effective Treatment for Benign Prostatic Hyperplasia and Prostatitis” “is a Natural, Highly Effective Treatment for BPH”
    “Indications: For benign prostatic hyperplasia (BPH), prostatitis and prostate disease.” “is effective in 95% of patients, significantly decreasing the prostate size” ” is effective in relieving BPH induced Prostatitis”

  214. August 18, 2011 at 2:57 pm

    Thank you for opening this conversation about FDA , i am impressed about this blog , thanxx again for valuable information

  215. August 18, 2011 at 2:59 pm

    starlightoko1982 :
    Thank you for opening this conversation about FDA , i am impressed about this blog , thanxx again for valuable information

  216. August 21, 2011 at 6:00 am

    I believe transparency is vital to make companies accountable for their actions.
    Thanks for sharing this great article.
    Regards

  217. August 24, 2011 at 10:10 pm

    This is great news byu FDA, the progress made is worth celebrating. Thanks for the article. This will help all walk of lifes.

  218. August 24, 2011 at 10:13 pm

    Great step towards a transparent future by FDA

  219. September 2, 2011 at 7:18 am

    Appreciate the openness, this is a step forward in providing more transparency between FDA and the public.

  220. September 6, 2011 at 6:27 am

    This is great news byu FDA, the progress made is worth celebrating. Thanks for the article. This will help all walk of lifes.

  221. September 16, 2011 at 2:10 pm

    A good initiative. Keep doing the good things!

  222. September 16, 2011 at 9:37 pm

    Although I think that great improvements have been made over the last couple of year, I also think that there’s always space for improvement when we talk about transparency. But I’m sure that FDA is taking the right actions to do it.

  223. master proyectos culturales
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  225. September 24, 2011 at 5:52 pm

    I think the word “transparency” is over-used in government today but nonetheless small steps like to have open platforms are important. Good work!

  226. tinnitus miracle
    October 1, 2011 at 8:25 am

    Indeed. Transparency sometimes does not mean everything is out for public. But I must agree that at least there are some effort has been done.

  227. Heli Schneider
    October 1, 2011 at 3:17 pm

    The Government is based on transparency and in matters affecting the well being of so many Americans such as those under the FDA, making the information accessible to as many citizens as possible and delivering it to them as fast as possible is critical.

  228. akismet-4e821a0e7ce70e00b6b27e6fd9f5611apregnancy signs
    October 2, 2011 at 12:22 pm

    transparency I hope in the government’s dictionary is visible to the public eyes.

  229. October 13, 2011 at 6:37 am

    This is a very good initiative wish the govt well

    Mike

  230. October 13, 2011 at 4:07 pm

    thank you for your post, yes transparency is a really important thing :)

  231. CFD
    October 14, 2011 at 10:46 am

    thank you for sharing this interesting post about transparency i found it really useful

  232. October 28, 2011 at 6:51 am

    I am really concerned if the good work will be continued or not in near future. To ensure that serious steps always needs to be employed.

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  234. November 7, 2011 at 3:56 pm

    Thanks for any other informative website. Where else may I am getting that kind of info written in such an ideal manner? I have a undertaking that I am just now working on, and I’ve been at the look out for such information.

  235. Deguisemen
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  237. Bareth
    November 10, 2011 at 6:16 am

    Very useful information. Тhank you for sharing.

  238. gichtsymptome
    November 19, 2011 at 10:23 am

    The sheer volume of comments indicate that approval of the FDA efforts, keep up the good work.

  239. Coaster video
    December 25, 2011 at 7:58 pm

    Web-based resource to better explain to the public what the agency does.FDA Basics includes several components, including:

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  240. Elle Franks
    December 28, 2011 at 2:33 pm

    It’s primary responsibility is protecting the public health through assuring the safety and efficacy of human and veterinary drugs, cosmetics, biological products, medical devices, the nation’s food supply and products that emit radiation.

  241. stalnir@wp.pl
    January 4, 2012 at 10:25 am

    Thank you for the link. He was helpful

    fdaweb :
    Consumers and others who would like to report problems with foods, drugs, biologics or medical devices to FDA can find out how to report them online at http://www.fda.gov/Safety/ReportaProblem/UCM059044.

  242. Derrick Ashley
    January 18, 2012 at 1:25 pm

    As I think, the Government has taken the right decision to eliminating the barriers between the American people and their Government. Transparency is most important for us.

  243. Jak zhubnout
    February 29, 2012 at 9:44 pm

    Thanks for this valuable post. There’s no doubt that someone should better protect the food we eat and the medicine we use.

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  247. Yvonne McGinnis
    June 20, 2012 at 9:27 pm

    Theoretically, there are a number of ways to improve FDA transparency. One of my favorites involves making ‘oneself’ vulnerable’ to others, in an exposed and engaged manner. Exposure is a temporary tand ransient state of being. It entails legislating in a clear and concise manner (e.g. policies, guidance documents, definitions; including defining undefined concepts). The same principle should be applied to the regulations, however, in simplistic terms, obvious, plain, frank, candid; open for discussion and always open for debate and comment.

    How do we accomplish some of these tasks? We accomplish these tasks by extending invitations to the general public in a welcoming manner (e.g. invitations to particicpate in a variety of outreach activities hosted by FDA and the White House). We extend invitations to the general public and members of the professional community to engage in transparancy dialogue. We can also consider exploiting some of the talents of a public relations expert, in order to target some of the individual population groups, in order to facilitate a more effective outreach activity and dialogue. We must be able to follow through on public feedback activities and social network sites, while eliminating the communication gaps that occur between local, state, tribal, and federal agencies. Most importantly, we must learn to listen and respond to inquiries, consumer needs, victims of crime, the sick, the elderly, those without a voice, and most importantly, listen to the needs of the American people.

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  252. Fingerprint
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  255. Daniel Chege
    August 14, 2012 at 7:42 pm

    What a great move for the FDA to be more transparent, and hopefully it will rid of the Top-Tier corruption and put the consumers safety first.

  256. PVC Stolarija
    September 8, 2012 at 6:03 pm

    I think this is a great initiative. Is interesting to see where the future is heading. Thank you…

  257. Isaak Roberts
    September 11, 2012 at 2:06 pm

    Not only one… two thumbs up! Great blog and thanks for sharing

  258. Ashwin Dubey
    September 16, 2012 at 11:23 pm

    Mumbai or Bombay whichever way you like to call it is a city of stardust and millions of dreams as they say. The financial capital of India, Mumbai has carved a specific place for itself on the map of the world. A conglomerate of seven islands, this city got its present name – Mumbai in 1996, earlier it was known as Bombay, the name given to it by the British. The never say die spirit and never ending energy of Mumbai has earned it an epithet of the ‘City which Never Sleeps’. Also famous for being the muse of several authors, Mumbai has been the main canvas against which award winning books like “Maximum City” and “Shantaram” have been written. Certainly there is no doubt that Mumbai is the “Maximum City”.

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  259. lanostech
    September 27, 2012 at 5:00 am

    Thanks for posting this wonderful blog.Do post more and more like this……..Thanks for the share………

  260. Autoškola
    October 10, 2012 at 5:36 am

    It is good to have some direct communication channels between people and government. Thanks for post

  261. website design
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  264. Sam Fyfe
    November 24, 2012 at 4:50 pm

    As someone who works in the regulatory industry, I found this article to be interesting even if it is a bit outdated that this point.

  265. gerald0123
    December 14, 2012 at 8:23 pm

    The FDA have an enormous responsibility and trust to protect the citizens of the United States. I am a mental health advocate and have been overall pleased with their monitoring of the safety and effectiveness of drugs that are used to treat mental illness. The increasing of transparency holds more feet to the fire, and that should result in an even better protection of the food and drugs available to us.

  266. Vaew Maliwan
    December 15, 2012 at 7:01 pm

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  268. Pablo
    February 11, 2013 at 12:07 pm

    Totally in agreement

  269. Perfilempleo
    March 6, 2013 at 10:43 am

    Transparency is what should prevail now in Governments so that the confidence of citizens follow not falling into a tailspin.

  270. tinnitus treatment options
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    April 3, 2013 at 2:13 am

    Transparency is very hard for most organizations since we are so secretive by nature…

  272. packers and movers in marathahalli bangalore
    April 7, 2013 at 7:48 am

    Great initiative by the FDI..way to go

  273. packers and movers in marathahalli bangalore
    April 7, 2013 at 7:51 am

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  274. Indrajeet Singh
    April 19, 2013 at 7:07 am

    Nice blog…

    Thanks a lot for this post….. and thanks for sharing your experience and view Introducing the FDA Transparency Blog.

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  277. roninathletics
    May 17, 2013 at 11:42 am

    I think this is a great initiative.

  278. FDA supporter
    May 18, 2013 at 7:38 pm

    Wow, wonderful. Amazing initiative. http://fda.gov

  279. Jayden
    June 5, 2013 at 8:00 am

    Consumers should have the right to request and see the FDA process if they need to or better yet made available to the public. Why would the agency want to hide the process or etc if nothing was against the law or along the regulations?

  280. David
    July 12, 2013 at 1:16 am

    Transparency is definitely needed in this day and age.

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  282. Bonnie Oak
    September 10, 2013 at 9:38 am

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  286. Blair
    April 2, 2014 at 7:04 am

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