# Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/adverse-event-reporting-for-outsourcing-facilities-under-section-503b-of-the-federal-food-drug-and-cosmetic-act/4c23f98f-eaf3-4ed1-8f57-33ea6ba03529

> FDA guidance document: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Issue date: October 08, 2015. Get complete insights and analysis.

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## Details

- Title: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2015-10-08
- Comment Close Date: 2015-05-17
- Last Changed: 2020-04-21
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2014-D-2138">FDA-2014-D-2138</a>

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