Archive for March, 2010

Transparency to Regulated Industry: How Can FDA Improve Its Guidance Development Process?

March 26, 2010 30 comments

The Task Force is collecting information on how to improve FDA's transparency to regulated industry.  We held three listening sesions with members of regulated industry on January 21, 27, and 28.  Transcripts and summaries of those listening sessions are available online and we are seeking comments from the public on the issues raised in those sessions, or other suggestions related to FDA's transparency to regulated industry. 

Our next question is:

What changes, if any, should FDA make to its guidance development process?

We look forward to your ideas.

Transparency Task Force

Upcoming Events: FDA Basics Webinar on the Inspection Process, March 25, 2 p.m. ET

March 22, 2010 58 comments

What kinds of products and facilities does the Food and Drug Administration (FDA) inspect? Who conducts these inspections?  What do they look for?

As part of FDA Basics, FDA is hosting a webinar where you can learn more about FDA’s inspection process.  The featured speaker, Michael Rogers, Deputy Director, Office of Regional Operations, will discuss how FDA staff inspect domestic and foreign establishments, check shipments of imported product, and collect and test samples for signs of contamination.  There will be time for questions following the presentation.

The free 30 minute webinar will be held on Thursday, March 25, at 2 p.m. ET.

You can find out more information about the webinar, including how to participate in the webinar on the FDA Basics homepage.  Click here for more information about the webinar.

Afia Asamoah

Transparency Initiative Coordinator

Agency Posts Review Documents for Some Popular Prescription Drugs

March 17, 2010 14 comments

FDA has posted on its website information from the agency’s review of 8 of the most prescribed brand name drugs that were approved before 1998.

The posted records are from the agency’s historical file of information that was previously disclosed under the Freedom of Information Act.  The records are posted as is and have not been previously posted due to the quality of some of the records.  The best available copies have been posted.

Approval information for the following drugs is now available on the FDA website:

This information can be found online by searching for the drug name.

Afia Asamoah

Transparency Initiative Coordinator

Final Phase of the Transparency Initiative: We Want Your Ideas

March 12, 2010 13 comments

As part of the final phase of the Transparency Initiative, we are looking for ideas from the public on how FDA can increase transparency with regulated industry, in order to foster a more effective and efficient regulatory process.  These comments will be used to inform draft recommendations the Task Force will put forward this spring on ways FDA may improve transparency to regulated industry.

FDA regulates products responsible for about 25 percent of the gross national product of the United States and the industries responsible for these products. Products regulated by the agency – biologics and blood products, human drugs, foods, medical devices, radiation-emitting devices, and veterinary medicines – are integral to public health and to the U.S. economy.

The Task Force held public meetings in June 2009 and November 2009.  Based upon input received so far, the Transparency Initiative has been divided into three phases. The first phase, creating a Web-based resource called “FDA Basics” to provide information on commonly misunderstood aspects of the agency, has been completed.  The second phase, improving FDA’s disclosure of information to the public, is underway and FDA intends to issue draft proposals for public comment soon.

For this final phase, we are particularly interested in comments on how FDA can make improvements in certain areas.  The first area we would like to hear comments about is:

What training and education should FDA provide for regulated industry about the regulatory process in general, or about new requirements?

We will post additional topics over the next couple of weeks.

We look forward to your ideas.

Transparency Task Force

Materials Available from FDA Basics Webinar on “Access to Investigational Drugs”

March 2, 2010 15 comments

Did you miss the FDA Basics webinar on “Access to Investigational Drugs”?

Check out the “What’s New” box on the FDA Basics home page to download materials from the webinar.

There, you will find a link to listen to the entire 30 minute webinar and you can download a copy of the presentation slides.

Afia Asamoah

Transparency Initiative Coordinator

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