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FDA-TRACK: Stay Informed on Agency-Wide Program Performance by Subscribing to FDA-TRACK Web Updates

September 1, 2010 11 comments

In April, FDA launched a web resource called FDA-TRACK that allows the public to track the agency's progress on a range of measures, including whether the agency is hitting its inspection targets and whether it is hitting its targets for completing reviews of product applications (see April 7 blog post).

Now, you can receive free email notifications when measures tracked on FDA-TRACK are updated by subscribing to "FDA-TRACK Updates."  "FDA-TRACK Updates" will send you an email alerting you when the performance data on FDA-TRACK are updated.  The subscription will allow you to choose how often you would like to recieve updates.  You can cancel at any time.

Thank you for your feedback thus far. We are working to incorporate suggestions and continuously improve the site. Please continue to visit and let us know what you think. Suggested changes and additional feedback can be submitted to FDATRACK@fda.hhs.gov.

Malcolm Bertoni, Assistant Commissioner for Planning at FDA


Upcoming Event: FDA Public Webinar About the “510(k) Premarket Review Process” and the “Use of Science in Regulatory Decision Making” Draft Reports, Tuesday, August 31, 1:00 p.m. ET

August 26, 2010 5 comments

FDA recently published two preliminary reports conducted by the Center for Devices and Radiological Health (CDRH).  The first preliminary report is an assessment of the process used to review certain medical device applications before they are marketed (known as the 510(k) process) and draft recommendations.  The second preliminary report is an assessment of the use of science in CDRH's regulatory decision making and draft recommendations.  This is the first step in determining what, if any, improvements to these processes FDA may implement.

Next week, FDA is hosting a webinar where CDRH officials will discuss the details of both reports.  There will be an opportunity to ask questions.

The live webinar will be held on Tuesday, August 31, at 1:00 p.m. ET.

There are a limited number of spots available for the webinar.  Click here for more information about the webinar, which includes a link to join the webinar on August 31.

FDA is also soliciting comments from the public on the draft reports via www.regulations.gov, docket number FDA-2010-N-0348.

Afia Asamoah, Transparency Initiative Coordinator

What is FDA-TRACK?

August 11, 2010 10 comments

FDA has posted a video explaining FDA-TRACK, the performance management system the agency launched in April (see April 7 blog post).   FDA-TRACK is a web resource that provides information about the breadth of FDA's activities to promote and protect the public health.  

The video features FDA Principal Deputy Commissioner, Dr. Joshua Sharfstein and FDA Center Directors Drs. Bernadette Dunham and Janet Woodcock.  View the video below, then check out the information currently available on FDA-TRACK about FDA's progress on a range of activities and let us know what you think.

We Want Your Feedback: Public Comment Period Ends July 20 (Feature Topic 4: Docket Management Process)

July 16, 2010 13 comments

On May 19, the Transparency Task Force released 21 draft proposals about information FDA should consider making available to the public. (see previous blog post). The time to provide the Task Force with your feedback on these draft proposals ends Tuesday, July 20.

The fourth topic being featured for your input is the Docket Management Process.  The draft proposal for public comment is about the following issue:

  • Whether FDA should change its current practice so that comments submitted to www.regulations.gov from people self-identified as individual consumers are posted to that Web site in the same manner as other comments. Click here to comment on and rate the proposal.  You can read the draft proposal, FDA's reason for the proposal, and other comments submitted so far.

The Task Force is asking for your feedback on  the content of the draft proposal and on which proposal(s) should be given priority.

The entire report is available on the FDA Web site.  Visit the web site, read the report, and comment there about any of the 21 draft proposals.  You can also submit a comment here (attachements are accepted at this site).

 

We look forward to your input.

Afia Asamoah

FDA Transparency Initiative Coordinator

We Want Your Feedback: Public Comment Period Ends July 20 (Feature Topic 3: Product Applications)

July 15, 2010 3 comments

On May 19, the Transparency Task Force released 21 draft proposals about information FDA should consider making available to the public. (see previous blog post). The time to provide the Task Force with your feedback on these draft proposals ends next Tuesday, July 20.

The third topic being featured for your input is Product Applications.  For example, some of the draft proposals for comment would allow FDA to:

  • Better explain FDA decisions — One proposal for comment is to allow FDA to explain when the agency declines to approve medical products.   Click here to comment on and rate the proposal.  You can read the draft proposal, FDA's reason for the proposal, and other comments submitted so far.
  • Provide more data to doctors and patients — A proposal would allow FDA to release summary data on safety and effectiveness from medical product applications when doing so would clear misconceptions or promote public healthClick here to comment on and rate the proposal.  You can read the draft proposal, FDA's reason for the proposal, and other comments submitted so far.
  • Support innovation for rare diseases — A proposal would allow FDA to explain that an abadoned application for an orphan drug could represent a significant therapeutic advance.  Click here to comment on and rate the proposal.  You can read the draft proposal, FDA's reason for the proposal, and other comments submitted so far.  
  • You can view and comment on all of the draft proposals about product applications here.

The Task Force is asking for your feedback on  the content of the draft proposal and on which proposal(s) should be given priority.

The entire report is available on the FDA Web site.  Visit the web site, read the report, and comment there about any of the 21 draft proposals.  You can also submit a comment here.

We look forward to your input.

Afia Asamoah

FDA Transparency Initiative Coordinator

We Want Your Feedback: Public Comment Period Ends Next Week (Feature Topic 2: Recalls)

July 13, 2010 7 comments

On May 19, the Transparency Task Force released 21 draft proposals about information FDA should consider making available to the public. (see previous blog post). The time to provide the Task Force with your feedback on these draft proposals ends next Tuesday, July 20.

The second topic being featured for your input is Recalls.  The draft proposals are about the following issues:

  • When a system is set up that provides FDA with the authority to require companies to submit certain information about recalled products to FDA, disclosing this information after FDA recieves it from the firm.   Click here to comment on and rate the proposal.  You can read the draft proposal, FDA's reason for the proposal, and other comments submitted so far.
  • Supporting efforts to address confusion in the marketplace about products that may be implicated in a food outbreak. Click here to comment on and rate the proposal.  You can read the draft proposal, FDA's reason for the proposal, and other comments submitted so far.
  • Disclosing when a product recall is terminated.  Click here to comment on and rate the proposal.  You can read the draft proposal, FDA's reason for the proposal, and other comments submitted so far.  

The Task Force is asking for your feedback on  the content of the draft proposal and on which proposal(s) should be given priority.

The entire report is available on the FDA Web site.  Visit the web site, read the report, and comment there about any of the 21 draft proposals.  You can also submit a comment here.

We look forward to your input.

Afia Asamoah

FDA Transparency Initiative Coordinator

We Want Your Feedback: Public Comment Period Ends Next Week (Feature Topic: Inspections)

July 12, 2010 5 comments

On May 19, the Transparency Task Force released 21 draft proposals about information FDA should consider making available to the public. (see previous blog post). The time to provide the Task Force with your feedback on these draft proposals ends next Tuesday, July 20.

 

Over the next week, we will feature some of the draft proposals on this Blog in order to get your feedback.  The first topic being featured for your input is FDA inspections

 

· The Task Force proposes to disclose certain information about the inspections it conducts.  Click here to comment on and rate the proposal.  You can read the draft proposal, FDA's reason for the proposal, and other comments submitted so far.

· The Task Force proposes to share with the public information about common inspection problems.  Click here to comment on and rate the proposal.  You can read the draft proposal, FDA's reason for the proposal, and other comments submitted so far.

 

The Task Force is asking for your feedback on  the content of the draft proposal and on which proposal(s) should be given priority.

 

The entire report is available on the FDA Web site.  Visit the web site, read the report, and comment there about any of the 21 draft proposals.  You can also submit a comment here.

 

We look forward to your input.

 

Afia Asamoah

Transparency Initiative Coordinator

FDA Launches Webpage with Summaries of Safety Data on New Drugs

June 17, 2010 17 comments

On Tuesday, June 15, FDA launched a web page where you can find summaries of safety information about recently approved drugs and a brief discussion of any steps FDA may be taking to address any identified safety issues. New drugs approved after September 27, 2007 will receive a safety summary within roughly two years of approval. The summaries address safety risks that were not identified during a drug's development or prior to FDA approval. FDA plans to publish summaries on a quarterly basis.

The first set of safety summaries for 26 products approved in 2008 can be found here.

You can find questions and answers about FDA's plan to post safety summaries here.

Afia Asamoah, Transparency Initiative Coordinator

Materials Available from FDA Basics Webinar on “Indoor Tanning: Risks of UV Radiation”

May 28, 2010 13 comments

Did you miss the FDA Basics webinar on “FDA’s Regulation of Tobacco Products”?

Check out the “What’s New” box on the FDA Basics home page to download materials from the webinar.  We have posted a link to listen to the entire 30 minute webinar as well posted a link to download a copy of the presentation slides.

You can find materials from past FDA Basics webinars here.

Afia Asamoah

Transparency Initiative Coordinator

FDA Unveils Draft Proposals on Agency Disclosure Policies for Public Comment

May 19, 2010 25 comments

Today, as part of the second phase of the Transparency Initiative, the Transparency Task Force released 21 draft proposals about FDA’s disclosure policies.  FDA is asking for comments on the proposals for 60 days.  After 60 days, FDA will use your input to recommend specific proposals to FDA Commissioner Dr. Margaret Hamburg for implementation.

You can read more about the transparency report FDA is releasing today in a Perspective article in the New England Journal of Medicine online, “Transparency at the U.S. Food and Drug Administration.”

FDA will not necessarily implement each of these ideas.  Some of the proposals require extensive resources to implement and some may require changes to regulations or legislation.

You can learn about the various ways to give us feedback here.

Visit the FDA Web site to read the report and comment on the proposals. You can let us know what you think about the proposals and what proposals FDA should prioritize, until July 20, 2010.

Afia Asamoah, Transparency Initiative Coordinator

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