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Benefit-Risk Frameworks May Be Coming To US FDA Advisory Committees

 
• By Sue Sutter

Structured assessments, which are currently publicly available only for approved products, could help frame questions for panel discussion of specific drugs under review; FDA also exploring ways to make completed frameworks more readily accessible.

3D illustration of a benefits versus risks matrix with pills and tablets positioned on it. Evaluation of drugs, healthcare concept

Now that the US FDA's drugs and biologics centers have completed their rollout of the benefit-risk framework for new products and efficacy supplements, the agency is eyeing ways to incorporate the structured assessment into the advisory committee process.

The benefit-risk framework (BRF) could help frame questions for advisory committee discussion, the agency said in an updated draft implementation plan, "Benefit-Risk Assessment in Drug Regulatory Decision-Making," released March...

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