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# Draft Guide on Drug Benefit-Risk Assessments
- URL: https://www.fdaweb.com/draft-guide-on-drug-benefit-risk-assessments/
- Published: 2021-09-30T12:00:00.000Z
- Updated: 2026-09-14T17:17:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150259

*Federal Register* notice: FDA has made available a draft guidance entitled *Benefit-Risk Assessment for New Drug and Biological Products*. The document is intended to provide drug sponsors and other stakeholders with a clearer understanding about how considerations about a drug’s benefits, risks, and risk management options factor into certain FDA pre- and postmarket regulatory decisions. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21194.pdf?ref=fdaweb.com).