Docket Number:
FDA-2018-D-2382
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

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All written comments should be identified with this document's docket number: FDA-2018-D-2382.