# Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/postmarketing-adverse-experience-reporting-for-human-drug-and-licensed-biological-products-clarification-of-what-to-report/89a5f407-ec41-4ec0-bf36-c5a19b96b776

> FDA guidance document: Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report. Issue date: August 27, 1997. Get complete insights and analysis.

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## Details

- Title: Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report
- 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: 1997-08-27
- Last Changed: 2020-04-27
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1997-D-0445">FDA-1997-D-0445</a>

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