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# Guide on Drug, Biologic Benefit/Risk Assessment
- URL: https://www.fdaweb.com/guide-on-drug-biologic-benefit-risk-assessment/
- Published: 2023-10-18T12:00:00.000Z
- Updated: 2026-09-14T14:13:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155588

FDA has published a guidance, *Benefit-Risk Assessment for New Drug and Biological Products*, to tell drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain FDA premarket and postmarket regulatory decisions on NDAs and BLAs. The [document](https://www.fda.gov/media/152544/download?ref=fdaweb.com) addresses decisions about any regulatory requirements for approval, such as the inclusion of a Boxed Warning in approved labeling, postmarketing study requirements and commitments, and risk evaluation and mitigation strategies.

The guidance does not directly address other regulatory decisions that may occur throughout the drug development lifecycle, FDA says, such as decisions on first-in-human trials of an investigational new drug and expanded access applications, which also may require the agency to consider information about the benefits and risks of an investigational or marketed drug for its proposed use.

The guidance contains an 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 Setting.