Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making FDA

This draft Plan from the Food and Drug Administration sets forth the FDA’s compliance with requirements under the Prescription Drug User Fee Act of 2012 that new framework for augmenting the transparency of its approval process for drugs and biologics.  The plan was developed in response to criticism that the drug-review process could benefit from more systematic risk–benefit assessment. The plan can be found here.

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