FDA issues draft guidance on factors considered in benefit-risk assessments for drugs and biologicals

30 September 2021

On Wednesday, the US Food and Drug Administration issued the draft guidance for industry, “ Benefit-Risk Assessment for New Drug and Biological Products.”

This guidance intends to clarify how considerations about a drug’s benefits, risks, and risk management options factor into FDA’s premarket and post-market regulatory decisions about new drug applications or biologics license applications.

These important considerations include:

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