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# Draft Guide on Opioid Benefit-Risk Assessments
- URL: https://www.fdaweb.com/draft-guide-on-opioid-benefit-risk-assessments/
- Published: 2019-06-21T12:00:00.000Z
- Updated: 2026-09-15T01:34:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144392

*Federal Register* notice: FDA has made available a draft guidance entitled “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.” The document describes the benefit-risk framework the agency uses in evaluating applications for opioid analgesic drugs. It also summarizes the information that should be included in an NDA to help with the agency’s benefit-risk assessment. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-06-21/pdf/2019-13221.pdf?ref=fdaweb.com).