Postmarketing Studies and Clinical Trials-Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Postmarketing Studies and Clinical Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act." This draft guidance revises the guidance for industry of the same name issued April 1, 2011. The draft guidance is being revised to describe the multiple factors that FDA considers, before requiring a postmarketing study or clinical trial for the purposes described in the Federal Food, Drug, and Cosmetic Act (FD&C Act), when determining the sufficiency of the reports under the FD&C Act and the active postmarket risk identification and analysis (ARIA) system available under the FD&C Act to meet these purposes. The draft guidance is also being revised to reflect certain provisions enacted under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act as they relate to postmarketing studies and clinical trials.