FDA’s Benefit-Risk Framework Should Be Used Earlier In Development, Firms Say

Early discussions based on the framework could engender more efficient drug reviews and aid industry in decisions on clinical programs, BIO and PhRMA note in comments to the agency.

Industry wants FDA to use its benefit-risk assessment framework to facilitate agency/sponsor discussions during NDA reviews and drug development, not just as a means to explain the agency’s thinking in approving a drug.

The framework, unveiled in March, allows drug reviewers to list the evidence and uncertainties surrounding five decision factors...

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