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FDA Expands On Endpoints That Can Support OUD Treatment Approval

August 06, 2018
FDA in a draft guidance published Monday (Aug. 6) lays out new types of endpoints -- beyond complete abstinence from drug use -- that can be used to develop and assess the efficacy of medication-assisted treatment (MAT) for opioid use disorder and be included on product labeling. The agency explains how sponsors can use patient-reported experiences, reductions in adverse outcomes of OUD, and changes in drug user patterns to support efficacy studies of MAT drugs. Randomized, blinded, controlled trial designs...


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