No Specific Drug-safety Issues Discussed at Board's First Meeting
On June 17, 2005 the FDA's Drug Safety Oversight Board (DSOB) held its first meeting, the primary purpose of which was to allow the Board an opportunity to discuss fundamental organizational matters. No specific drug-safety issues were discussed at the Board's first meeting. The FDA said it will post a summary of this first Drug Safety Oversight Board meeting at its primary web site -- www.fda.gov -- in approximately one week, and will do likewise after each future DSOB meeting.
In connection with this first Drug Safety Oversight Board meeting, Dr. Steven Galson, Acting Director for the Center for Drug Evaluation and Research (CDER) made these comments:
The Drug Safety Board is a central component of FDA’s commitment to communicating in a transparent manner emerging and important drug safety information to health care practitioners and the public. I believe today’s meeting set the stage that will allow the board to conduct timely and comprehensive evaluations of emerging drug safety concerns and assist FDA in ensuring that safe and effective drugs are available for patients. I look forward to working with this Board, comprised of some of the nation’s most experienced drug safety experts, as they come together in this important task.
As background, the FDA announced the identity of Drug Safety Oversight Board members in a May 18, 2005 press release. Essentially, the Board is comprised of scientists who have been appointed to serve by the FDA's Acting Commissioner from offices throughout the FDA as well as from other federal agencies. The board includes 15 voting members who will meet on a regular basis. A list of the Board members can be viewed by use of this link:
On May 4, 2005 the FDA published its internal policy for the Drug Safety Oversight Board -- called the MAPP (manual of policies and procedures). The MAPP for the Drug Safety Oversight Board is available on the FDA's CDER Web site:
(Posted by: Tom Lamb)