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Archive for July, 2010

Find Out More About FDA: New Questions and Answers Available on FDA Basics

July 28, 2010 11 comments

Based on comments from the public, FDA has added 7 new questions to FDA Basics, the web-based resource that provides information about FDA and what the agency does.  Below is a sample of some of the new questions about FDA and the work we do.

When and why was FDA formed?

How do I report a bad reaction to medicne or medication error to FDA?

What is a 'recall'?

Is FDA responsible for regulating pesticides that are used in animal products?

Find out answers to these questions and more at FDA Basics!  

Afia Asamoah, Transparency Initiative Coordinator

Materials Available from FDA Basics Webinar on “FDA’s Safety Monitoring of Approved Vaccines”

July 22, 2010 7 comments

Did you miss the FDA Basics webinar about how FDA reviews vaccine safety after a vaccine is approved? Do you know why it is important to have different types of systems to perform safety surveillance for approved vaccines?

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 view and listen to the 30 minute webinar as well as 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

New FDA Basics Video Available about FDA’s Regulation of Tobacco Products

July 20, 2010 18 comments

As part of FDA Basics, FDA has posted a new video with Dr. Lawrence Deyton, director of FDA's Center for Tobacco Products.  Dr. Deyton discusses FDA's new authority to regulate tobacco products.  View the video below.

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

Upcoming Event: FDA Basics Webinar on FDA’s Safety Monitoring of Approved Vaccines, Tuesday, July 13, 2 p.m. ET

July 8, 2010 3 comments

Did you know that FDA’s review of vaccine safety doesn’t stop once a vaccine is approved?  Why is it important to have different types of systems to perform safety surveillance for approved vaccines?

As part of FDA Basics, FDA is hosting a webinar where you can learn more.  The featured speaker, Andrea Sutherland, MD, MPH, Msc, a medical officer in the Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, will give an overview about vaccine safety surveillance, including the Vaccine Adverse Event Reporting System (or VAERS), and efforts underway to improve safety monitoring.  After the presentation, there will an opportunity to ask questions.

The free 30 minute webinar will be held on Tuesday, July 13, at 2 p.m. ET.

For more information about the webinar, including instructions about how to join the webinar, click here.

There are a limited number of spots available for the webinar.  Webinar materials will be posted on the FDA Web site.

Afia Asamoah, Transparency Initiative Coordinator 

Materials Available from FDA Basics Webinar on “FDA’s Regulation of Tobacco Products — The Year in Review and Looking Forward”

July 6, 2010 4 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

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