CDER to Launch Drug Risk Management Board

Regulatory NewsRegulatory News | 21 January 2020 |  By 

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.
“The DRMB will continue to build on the success of the Safety First Initiative, established post-FDAAA, to emphasize the importance of a product’s benefit-risk balance throughout the entire lifecycle. The Safety First Steering Committee, overseeing the Safety First Initiative, will be sunset and the DRMB will assume the next phase of its responsibilities. The DRMB will enable CDER’s modernization of its marketed product safety signal management through enhanced facilitation, coordination, and oversight across our various CDER safety initiatives,” Woodcock added.

She also pointed to recent accomplishments of the existing workstreams, including:


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