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# Postmarketing Study and Clinical Trial Guidance
- URL: https://www.fdaweb.com/postmarketing-study-and-clinical-trial-guidance/
- Published: 2019-10-23T12:00:00.000Z
- Updated: 2026-09-15T01:58:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145313

FDA has issued a draft guidance, *Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act*, with information on the provision in the law authorizing FDA to require certain postmarketing studies and clinical trials for certain prescription drugs and biological products. The [document](https://www.fda.gov/media/131929/download?ref=fdaweb.com) describes the agency’s statutory authority to require certain postmarketing studies and clinical trials under section 505(o)(3), and gives an overview of the types and purposes of such studies and trials. It also describes those types of postmarketing studies and clinical trials that are agreed upon between FDA and an applicant.

The agency says the draft revises a 2011 guidance by adding information on section 505(o)(3) and reflecting 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.