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FDA 101 Curriculum

September 16, 2009 Leave a comment Go to comments

Part of FDA’s transparency initiative is to better explain to the public what the agency does, in a useful, and user-friendly format. The task force would like your help in coming up with a list of questions about the FDA that you would like answers to. For example, possible questions can include: What products does FDA regulate? How do you find out if a medicine is approved by FDA? Your suggestions will be used by the task force to develop a FDA 101 curriculum for consideration by Commissioner Hamburg.

Our question is:

What questions and topics should be included in a FDA 101 curriculum? How should the agency present that information?

We look forward to your feedback and thanks for your participation!

Transparency Task Force

  1. covert hypnosis
    September 17, 2009 at 8:11 am

    My question would be related to a somewhat relevant topic…
    Does FDA, after approving a vaccine, also publish it’s deficiencies anywhere?

  2. John Mack
    September 18, 2009 at 11:38 am

    What Guidelines does FDA follow when reviewing drug promotions via Internet?

  3. Kristine Maxwell
    September 23, 2009 at 11:16 am

    FDA should place the MedWatch 3500A forms on line concerning drugs and allow the public to access the reports. The medical device side is far more technologically advanced and consumers can easily find out about adverse events concerning medical devices. On the drug side of FDA, the database is outdated and nearly impossible to search or read. This is unacceptable because the public has a right to know about the adverse events caused by the drugs approved and monitored by FDA. This critical information is being denied to patients and it could save people from serious long term side effects. It also gives patients more information to make more informed decisions.

  4. Julia
    September 24, 2009 at 8:22 pm

    The only thing I can think to ask is: Is there a website where I (or other consumers) can go to see if medicine we may have is approved?

  5. Barbara Faha
    September 29, 2009 at 9:50 am

    I agree with John Mack that the FDA website is almost impossible to search effectively. The public cannot benefit from increased transparency if the FDA website is so unwieldy. Many searches result in being directed from link to link to link with no end in sight. Other searches yield nothing. A perfect example: I searched the name of a company I KNOW has interacted with FDA on a new medical device (rec’d 501K exempt status), nothing. Filled in ALL the boxes on CDRH’s search page, nothing. Omitted everything from the search boxes except the “Owner/Operator Number” , bingo, there it was. Arggghhh.

  6. September 30, 2009 at 1:17 am

    The FDA should explain what documents are necessary to support clinical trial data. Right now, FDA talks about “adequate and accurate subject case histories” and not much else. There should be a comprehensive index of essential documents as there is in the International Conference on Harmonization E6 document (Good Clinical Practice). An example would be what correspondence is it necessary to keep? E6 tells us. FDA does not.
    People conducting clinical trials are often confused by what FDA requires. As a result, we have “regulation by rumor.” Clear, constructive guidance would be very helpful. ICH is at:
    http://www.ich.org/LOB/media/MEDIA482.pdf

  7. Julia
    October 3, 2009 at 9:36 am

    I have to say that it is really hard to find your blog. Honestly, I came across it by accident, and don’t even know how I got here. But, if you are wanting to educate the public, I suggest that you make it easier to find and access your blog.

  8. Lynne Faraone
    October 8, 2009 at 2:27 pm

    I believe this to be a step in the right direction,but as a consumer of drugs i have learned the hard way,of the issues you face.There really has to be one answer,there must be fire walls in place between the FDA and the pharmaceutical companies,people or companies who can potencially profit from FDA decisions on drugs,must not be part of the discussion.Clinical trials,not paid for by those who will benefit.Full and absolute disclosure,the good and the bad,are an absolute must.The task is daunting but neccasary,for the FDA to gain back its reputation as protector of the public.

  9. Karen P.
    October 12, 2009 at 12:55 am

    What do I need to know about food allergies?
    FDA has already partially answered this question in its educational material titled “Food Allergies: What You Need to Know” available at http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm079311.htm .
    However, the “About Other Allergens” section, where FDA advises consumers to “read the food label’s ingredient list carefully to avoid the food allergens in question” is both disingenuous and dangerously misleading.
    FDA is well aware that consumers with allergies not covered under the FALCPA do “not receive sufficient information from food labels to protect their safety”.
    (Reference: Laura E. Derr, When Food is Poison: the History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 FOOD & DRUG L.J. 65, 109 (2006).)
    When my daughter was first diagnosed with a life-threatening allergy to sesame, I was not concerned about FDA’s ability to protect the public health. I would now classify myself as a critic of the agency. I would like to regain trust and confidence in the FDA, but that trust has to be earned. How can I trust FDA when I know that, although understanding the labeling loopholes that still exist for many allergens, FDA did not explain the risks to the public?
    Please don’t sugarcoat the information – explain the intricacies of labeling (ex. – flavors, spices, additives, sources of ingredients, genetically modified food, limited focus on containing cross-contamination for allergens not covered under the FALCPA). Lives may depend on consumers understanding this information.
    In addition, the following quote is outdated: “the law identifies the eight most common allergenic foods” as sesame is now considered by the scientific community to be among the top eight food allergens in the U.S.
    (Reference: “Sesame Allergies on the Rise in U.S.: Sesame Seed Allergy Now Among Most Common Food Allergies” by Charlene Laino available at http://www.webmd.com/allergies/news/20090316/sesame-allergies-on-the-rise-in-us ).

  10. nike air
    October 15, 2009 at 9:55 pm

    People conducting clinical trials are often confused by what FDA requires.

  11. October 21, 2009 at 2:47 pm

    FDA – used to – have one of the most transparent government sites in the world. I agree with the comment that it is impossible to search, so just use Google advanced search and limit searches to site:fda.gov and the results are different and much better. I personally dont bother with the site search function on fda.gov anymore.
    Almost all the questions asked on here so far can be answered on the site, and many organizations and universities provide courses and materials that tell people where to find the answers. A consumer should not be expected to spend $500 for a day course or $5,000 for a semester but any industry or investor that wont invest in that, frankly, is just not interested in finding the real answer. (Perhaps some keep looking because they want the answer that they WANT, not the right answer.) If they want the latest scientific requirements they need to hire staff to know that, and not count on FDA to know it for them. FDA will never be able to be as current as every single manufacturer on every product, so each company has an obligation to stay on top of its own products. That’s they way the law is writen and the way the core function of FDA is designed. The costs of research and approval are on the applicant, not the government.
    The OLD CDRH website leading interested persons through its site and the regulatory process for devices was wonderful, but in the web redesign, instead of making the other Centers provide that, under the banner of uniformity, Device Advice is buried and much harder to navigate now. Bring it back. Make all the Centers follow it.
    Until FDA is fully staffed, investing in transparency diverts the little staff there is from appprovals and compliance.
    In sum, at least since its response to the AIDS crisis, FDA has been transparent to professionals and organizations who need to know and who make the effort to learn. However, the new website does not improve transparency but makes it worse.

  12. FDA Approval
    October 26, 2009 at 2:03 pm

    Not only is transparency needed. There needs to be a simple, yet detailed way for the “red tape” to be in place. With the different phases and backlog for FDA approval, its truly not remarkable that there is so much confusion.

  13. student and teacher
    November 16, 2009 at 8:16 am

    There are organizations that already have excelelnt FDA 101 curriculums, including Keck Graduate Schools at http://www.kgi.edu/x7640.xml
    and Johns Hopkins at http://advanced.jhu.edu/registration/description/?Dept=410&Number=649.
    The courses have been ongoing in some cases for ten+ years and get excellent feedback. FDA should reach out to the contacts there and see what students have said are helpful.

  14. locksmiths
    November 18, 2009 at 4:58 pm

    The OLD CDRH website leading interested persons through its site and the regulatory process for devices was wonderful, but in the web redesign, instead of making the other Centers provide that, under the banner of uniformity, Device Advice is buried and much harder to navigate now. Bring it back. Make all the Centers follow it.
    ——-
    24 hour locksmiths

  15. David Ross
    December 14, 2009 at 6:57 am

    I agree that the FDA website is almost impossible to search effectively. I think website should be simple & user friendly as well. For more information just check
    http://www.compliancepanel.com/

  16. Anthony Masiello
    December 31, 2009 at 9:04 pm

    I have searched google for FDA info. and it is very difficult to find a clear explanation on certain issues. How can there be so much confusion?

  17. California Blogger
    January 28, 2010 at 4:10 am

    Alternative dietary supplement information will always be appreciated by the public.

  18. josalinda
    January 31, 2010 at 5:29 pm

    i like it. “FDA should place the MedWatch 3500A forms on line concerning drugs and allow the public to access the reports. The medical device side is far more technologically advanced and consumers can easily find out about adverse events concerning medical devices. On the drug side of FDA, the database is outdated and nearly impossible to search or read. This is unacceptable because the public has a right to know about the adverse events caused by the drugs approved and monitored by FDA. Schools at http://www.joingame.net This critical information is being denied to patients and it could save people from serious long term side effects. It also gives patients more information to make more informed decisions.” nice post. thank you.

  19. Aloja Vera
    February 9, 2010 at 9:22 am

    I agree with Californian Blogger “Alternative dietary supplement information will always be appreciated by the public.”

  20. James
    April 5, 2010 at 8:10 am

    Yeas, it is very difficult to navigate. http://www.squidoo.com/learnhypnosishowto is organised is much more efficiently

  21. Daniel
    June 2, 2010 at 11:04 am

    I agree with Carl I came across this site a few days ago doing a Google search then I thought I would comment at a later time. well I left the page thinking I could come back to it again, it took me about 2 days to find the page again. You need to make information standard and easy to find and easy to navigate doing searches on the FDA Web site is almost a joke. No disrespect given here but most people can barely turn on a computer much less know how to use search syntax and complex searches.

  22. cheat point blank
    August 12, 2010 at 3:46 am

    I have searched google for FDA info. and it is very difficult to find a clear explanation on certain issues. How can there be so much confusion?

  23. December 20, 2010 at 9:22 pm

    The website needs to be user friendly with different layers enabling people with minimal skills to get basic information yet allow others to drill deep for more detailed knowledge. In the past I have found the information I needed but it took some time and skill in the search process.

  24. May 11, 2011 at 10:31 am

    How does FDA regulate drugs through the internet? It seems there are more and more medicanal drugs available every day.

  25. September 17, 2011 at 6:50 pm

    Is this FDA 101 already made? Where can I get it?

  26. October 11, 2011 at 7:30 am

    What Guidelines does FDA follow when reviewing drug promotions via Internet .?

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