# 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 Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/postmarketing-studies-and-clinical-trials-determining-good-cause-for-noncompliance-with-section-505o3eii-of-the-federal-food-drug-and-cosmetic-act-draft-guidance-for-industry/e8ac2a5e-a08e-4bc6-b2bd-5feb7968f8ae

> FDA guidance document: 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 Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry. Issue date: July 14, 2023. Get complete insights and analysis.

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## Details

- Title: 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 Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry
- Communication Type: Guidance Document
- Product Type: other
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2023-07-14
- Comment Close Date: 2023-09-12
- Last Changed: 2023-07-14
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-0559">FDA-2023-D-0559</a>

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