USA – Implementation of Section 505(o)(3) – Postmarketing Studies and Clinical Trials

This guidance describes FDA’s statutory authority to require certain postmarketing studies and clinical trials under section 505(o)(3) of the FD&C Act (i.e., postmarketing requirements (PMRs))and provides an overview of the types and purposes of such studies and clinical trials. This guidance also describes those types of postmarketing studies and clinical trials that are agreed upon (i.e., postmarketing commitments (PMCs)) between FDA and the applicant.

This draft guidance is a revision of the guidance for industry Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act published in April 2011. This revised guidance provides information on implementation of sections 505(o)(3)(D)(i) and (ii) of the FD&C Act. This guidance also reflects certain provisions enacted under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act as they relate to postmarketing studies and clinical trials.8 37 This guidance does not distinguish between prescription drugs with active ingredients that are controlled substances and other prescription drugs because, at this time, the Agency does not intend to treat controlled substances differently than other prescription drugs under 505(o). Once finalized, this guidance will replace the April 2011 guidance.

This guidance does not apply to nonprescription drugs approved under a new drug application or to generic drugs approved under section 505(j) of the FD&C Act.

The Glossary defines many of the terms for purposes of this guidance. Words or phrases found in the Glossary appear in bold italics at first mention…