US FDA seats new panel on product-specific drug safety

31 December 2001 21:15  [Source: ICIS news]

HOUSTON (CNI)--The US Food and Drug Administration (FDA) said Monday it is establishing a new drug safety and risk management (DSRM) panel to monitor general and product-specific drug safety issues.

The new policy guidance group will operate as a subcommittee of the FDA's longstanding advisory committee for pharmaceutical science.

"The new subcommittee," FDA said in a message distributed today, "is comprised of nationally-recognised experts in the areas of risk perception, risk management, pharmacoepidemiology, clinical pharmacology, clinical research and medication errors."

FDA said it created the DSRM panel to meet "the need for expert advice on complex drug-specific safety issues as well as methods of risk assessment, management, and communication." These issues, FDA added, "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."

A list of members of the DSRM subcommittee can be found at: http://www.fda.gov/ohrms/dockets/ac/cderrosters/DSaRM Public Roster.doc.

The DSRM panel will hold its first public meeting in the second quarter 2002, FDA said.

By: Joe Kamalick
+1 713 525 2653

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