FDA: Monitoring Drug Safety

Drug Safety

DHHS Secretary Michael Leavitt and Acting FDA Commissioner Lester M. Crawford unveiled a new vision for the FDA that they hope will promote a culture of openness and enhanced oversight within the agency.

The agency plans to create a new independent Drug Safety Oversight Board (DSB) to review the management of drug safety issues within the Center for Drug Evaluation and to provide emerging information to health providers and patients about the risks and benefits of medications. (See Dr. Stefanacci’s commentary on page 176.) official canadian pharmacy

As the FDA develops new communications formats, it will be soliciting public input on how it should manage potential concerns associated with disseminating emerging information prior to regulatory action. The agency will issue draft guidance on procedures and criteria for identifying drugs and information for its Drug Watch Web page.