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GUIDANCE DOCUMENT

Stimulant Use Disorders: Developing Drugs for Treatment October 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-1848
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of stimulant use disorders. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s or Agency’s) current recommendations regarding the overall development program and clinical trial designs for the development of drugs to support indications for treatment of moderate to severe cocaine use disorder, treatment of moderate to severe methamphetamine use disorder, or treatment of moderate to severe prescription stimulant use disorder. This draft guidance is intended to serve as a focus for continued discussions among Center for Drug Evaluation and Research staff (particularly the Division of Anesthesiology, Addiction Medicine, and Pain Medicine, or the division), pharmaceutical sponsors, the academic community, and the public. This guidance does not address treatment of intoxication or poisoning with various stimulants or treatment of withdrawal from stimulants.

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-1848.

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