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# Guide on Drug Benefit-Risk Assessments
- URL: https://www.fdaweb.com/guide-on-drug-benefit-risk-assessments/
- Published: 2023-10-20T12:00:00.000Z
- Updated: 2026-09-14T14:13:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155613

*Federal Register* notice: FDA makes available a final guidance entitled “Benefit-Risk Assessment for Human Drug and Biological Products.” The document is intended to provide drug sponsors and other stakeholders with better clarity on how considerations about a drug’s benefits, risks, and risk management options factor into FDA’s pre- and post-market regulatory decisions on NDAs/BLAs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-10-20/pdf/2023-23161.pdf?ref=fdaweb.com).