FDA DSOB Meeting

Posted in Prescription Drugs Saturday June 18, 2005

The Food and Drug Administration’s (FDA) Drug Safety Oversight Board (DSOB) held its inaugural meeting on June 17, 2005. The Board met to discuss organizational issues and logistics.

The meeting also included an overview of the draft Drug Watch Guidance, the Board policies and procedures and information about routine administrative activities. No product specific issues were discussed. FDA will post summaries of the board meetings at www.fda.gov approximately one week after each meeting.

“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,” said Dr. Steven Galson, Acting Director for the Center for Drug Evaluation and Research (CDER).

“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.”

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