# Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/postmarketing-studies-and-clinical-trialsimplementation-of-section-505o3-of-the-federal-food-drug-and-cosmetic-act-guidance-for-industry-draft-guidance-for-industry/956f83ff-a6ef-4206-a544-56a3e8a65ee9

> FDA guidance document: Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry: Draft Guidance for Industry. Issue date: October 25, 2019. Get complete insights and analysis.

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## Details

- Title: Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry: Draft Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2019-10-25
- Last Changed: 2022-02-01
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2009-D-0283">FDA-2009-D-0283</a>

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