Issue Date: May 13, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Draft
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework
The purpose of this guidance is to describe the benefit-risk assessment framework that the 17 Agency uses in evaluating whether applications for opioid analgesic drugs meet the standard for 18 approval under section 505 of the Federal Food, Drug, and Cosmetic Act. This guidance 19 summarizes the information that should be included in a new drug application for an opioid 20 analgesic drug to facilitate the Agency’s benefit-risk assessment.
Download the Guidance Document
