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# Guide on Postmarketing Study Noncompliance
- URL: https://www.fdaweb.com/guide-on-postmarketing-study-noncompliance/
- Published: 2023-07-14T12:00:00.000Z
- Updated: 2026-09-14T18:44:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154882

*Federal Register* notice: FDA is making available a draft guidance entitled “Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act.” The document describes the factors FDA considers when determining whether an applicant has demonstrated good cause for failure to comply with the timetable for completing required postmarketing studies or clinical trials. It also provides information on relevant procedures, including how an applicant should communicate with FDA about its compliance with the required studies and trials and describes actions it may take for noncompliance with the requirements. To view the notice, click [here](https://public-inspection.federalregister.gov/2023-14905.pdf?ref=fdaweb.com).