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# Drug, Biologicals Benefit/Risk Assessment Guidance
- URL: https://www.fdaweb.com/drug-biologicals-benefit-risk-assessment-guidance/
- Published: 2021-09-29T12:00:00.000Z
- Updated: 2026-09-14T17:16:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150248

FDA has published a draft guidance, *Benefit-Risk Assessment for New Drug and Biological Products*, to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that FDA makes about NDAs and BLAs. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/benefit-risk-assessment-new-drug-and-biological-products?ref=fdaweb.com) gives important considerations that factor into CDER and CBER benefit/risk assessments, including how patient experience data can be used to inform the benefit/risk assessment.

It then discusses how sponsors can inform the agency’s benefit/risk assessment through the design and conduct of a development program, as well as how they may present benefit and risk information in a marketing application. And it discusses opportunities for interaction between FDA and sponsors to discuss benefit/risk considerations in connection with the development of an NDA or BLA.

The guidance contains Introduction, FDA’s Approach to the Benefit/Risk Assessment of New Drugs and Biologics, Important Considerations for FDA’s Premarket Benefit/Risk Assessment of Drugs and Biologics, Activities That Occur in Premarket Development That Inform Benefit/Risk Assessment, and Benefit/Risk Assessment Conducted in the Postmarket.