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Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry Draft Guidance for Industry February 2022

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

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

This guidance is written in response to the statutory requirements of section 3001(b) of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, which directs the Food and Drug Administration (FDA) to issue or update existing guidance to help address challenges to developing nonaddictive medical products to manage pain. In keeping with the mandate of section 3001(b), and considering the severity of the ongoing opioid crisis, this guidance is also intended to assist sponsors in the development of alternatives to opioids for the management of acute pain. Accordingly, this guidance addresses FDA’s current thinking about three specific topics: development of non-opioid analgesic products for acute pain, labeling claims, and expedited programs as they pertain to this purpose.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-N-0556.

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