FDA creates new drug safety subcommittee
On Dec. 18, 2001, the Food and Drug Administration (FDA) announced the creation of a new Drug Safety and Risk Management Subcommittee to the Advisory Committee for Pharmaceutical Science.
The new subcommittee is composed of nationally recognized experts in the areas of risk perception, risk management, pharmacoepidemiology, clinical pharmacology, clinical research, and medication errors who will advise FDA on general and product-specific safety issues. The subcommittee was created because of the need for expert advice on complex drug-specific safety issues as well as methods of risk assessment, management, and communication, the FDA says. These issues play a role in FDA’s overall evaluation of the risk/benefit ratio of drugs, and are common topics of discussion at advisory committee meetings.
The roster for the subcommittee can be found on the FDA web site at www.fda.gov/ohrms/dockets/ac/cderrosters/committees.htm. The subcommittee is expected to have its first public meeting in the spring of 2002.
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