USA – FDA to launch Drug Risk Management Board this month

Later this month, the US Food and Drug Administration (FDA) will formally launch its Drug Risk Management Board (DRMB) to coordinate safety activities among offices, Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said in an email to staff on Tuesday.

Woodcock said the DRMB is a center-level body that will also rapidly analyze and resolve drug safety issues by facilitating decision making across CDER on major clinical and quality-related safety issues with marketed products. The board is also expected to help foster better communications across the center.

In addition, the DRMB will continue the center-level Drug Risk Management Steering Committee’s work to facilitate and coordinate all new and existing marketed product safety initiatives across CDER, including the modernization of CDER’s framework capabilities for safety surveillance of marketed products. Patrizia Cavazzoni, CDER deputy director for operations, will serve as the committee’s chair, Woodcock said, noting that she will be supported by the drug safety operations staff in the Center Director’s office…