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FDA Announces Membership of Drug Safety Oversight Board

Completing another step in implementing its drug safety initiatives, the Food and Drug Administration (FDA) is announcing the members of the Agency's new Drug Safety Oversight Board (DSB). The DSB will provide oversight and advice to the Director of FDA's Center for Drug Evaluation and Research (CDER) on the management of important drug safety issues and will manage the flow of emerging safety information through FDA's recently proposed Drug Watch Web site to health care professionals and patients.

The DSB is comprised of scientists who have been appointed to serve by FDA's Acting Commissioner from offices throughout FDA and other federal agencies. The board includes 15 voting members who will meet on a regular basis. An initial organizational meeting will take place early this summer.

Susan K. Cummins, MD, MPH will serve as the Executive Director of the Drug Safety Oversight Board.   CDER Deputy Director Dr. Douglas Throckmorton will serve as the non-voting Chair. Within CDER, members were selected from eight offices. The Board will also include an employee from FDA's Center for Devices and Radiological Health, and one from the Center for Biologics Evaluation and Research. Members and alternates have also been selected from the Veterans Administration and the National Institutes of Health. (See attached list for names of members.)

The DSB may engage the Chairs of FDA Advisory Committees and other external scientific experts as consultants, as well as consumer and patient representatives to present their views regarding emerging drug safety issues.

When possible, the DSB will draw upon existing CDER/FDA working groups and committees and coordinate with ongoing activities.

On May 4, 2005 , FDA published its internal policy called the MAPP (manual of policies and procedures) for the Drug Safety Oversight Board.   The roles described in the Mapp include oversight of the management of important drug safety issues. The MAPP for the Board is available on the CDER Web site ( http://www.fda.gov/cder/drugSafety.htm), along with the draft Drug Watch Guidance and Questions and Answers about this initiative.

Link to list of names: www.fda.gov/cder/drug/DrugSafety/DSOBMembers.pdf

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