FDA’s CDER to launch Drug Risk Management Board

FDA’s Center for Drug Evaluation and Research will launch a new body in January, the Drug Risk Management Board, to “coordinate major, complex, and high-impact safety issues,” CDER Director Janet Woodcock told center staff Tuesday in an email.

The DRMB will facilitate decision-making across CDER on “major clinical and quality-related safety issues with marketed products,” Woodcock said. It will also provide guidance on the generation of responses to and communication about major safety issues, and communicate recommendations and decisions to Woodcock about safety issues. ...