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GUIDANCE DOCUMENT

Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry August 2018

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is intended to assist sponsors in developing drugs for medication-assisted treatment of opioid use disorder (OUD). This guidance addresses the clinical endpoints acceptable to demonstrate effectiveness of such drugs.


Submit Comments

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: https://www.federalregister.gov/documents/2018/08/07/2018-16813/opioid-use-disorder-endpoints-for-demonstrating-effectiveness-of-drugs-for-medication-assisted .

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