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# Draft Guide on Postmarketing Studies/Trials
- URL: https://www.fdaweb.com/draft-guide-on-postmarketing-studies-trials/
- Published: 2019-10-24T12:00:00.000Z
- Updated: 2026-09-15T01:58:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145324

*Federal Register* notice: FDA has made available a draft guidance entitled “Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.” The guidance revises a 2011 document to describe the multiple factors that the agency considers before requiring a postmarketing study or clinical trial for the purposes described in the federal Food, Drug, and Cosmetic Act. It is also being revised to reflect 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. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-23312.pdf?ref=fdaweb.com).