FDA wants ideas for transparency

Agency considering Web enhancements, training

The Food and Drug Administration is upgrading its Web communications and considering other moves to increase transparency in its dealings with industry and consumers.

The FDA has started the third phase of a three-part program to solicit input and ideas for how to improve its openness, according to a notice in the Federal Register dated March 12. Public comments are due by April 12.

The FDA created a Transparency Task Force last year to consider recommendations for increasing the availability of information about agency activities in regulating drugs, foods, medical devices and many other products.

The first phase of program was the creating a new Web-based resource called “FDA Basics” that provides basic information on the agency and its purview.

In the second phase, the FDA considered requests from the public and from industry executives to provide more information in emerging and evolving areas, such as how to deal with safety issues concerning FDA-related products and how and when the FDA should begin communicating information about the risks of those products. Task force members also heard requests to address the availability of information about product applications that are withdrawn and about pending applications.

The FDA said in a news release that to address those Phase Two questions, it will publish draft proposals in weeks.

For the third phase, the FDA is interested in comments on training and education for regulated industries, distributing information on its  guidance development process, and how the agency can provide timely answers to industry questions about specific regulatory issues.

About the Author

Alice Lipowicz is a staff writer covering government 2.0, homeland security and other IT policies for Federal Computer Week.

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