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NEW ADVISORY SUBCOMMITTEE CREATED ON DRUG SAFETY AND RISK MANAGEMENT

The Food and Drug Administration (FDA) is announcing the creation of a new Drug Safety and Risk Management Subcommittee to the Advisory Committee for Pharmaceutical Science.

The new subcommittee is comprised 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 impetus for the creation of the subcommittee is the need for expert advice on complex drug-specific safety issues as well as methods of risk assessment, management, and communication.

These issues play a significant 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 following FDA website: http://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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