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GUIDANCE DOCUMENT

Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry June 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry

Submit Comments by 08/20/2019

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-13221


Docket Number:
2019-13221
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.