CDER to Launch Drug Risk Management Board

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:

• finalization of MAPP 4121.3 on the Newly Identified Safety Signal (NISS) and the development of the Lifecycle Signal Tracker tool in CDER’s new IT platform to support the NISS process
• draft guidance for Providing Regulatory Submissions in Electronic Format: IND Safety Reports
• updated guidance for Postmarketing Studies and Clinical Trials – Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act,
• an updated MAPP 6700.9 for FDA Posting of Potential Signals of Serious Risks Identified by the Adverse Event Reporting System,
• draft Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff
• advancement of the FAERS II implementation roadmap.