# Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/postmarketing-adverse-event-reporting-for-nonprescription-human-drug-products-marketed-without-an-approved-application/95170478-4748-49e7-88f5-b582dc43e2ee

> FDA guidance document: Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application. Issue date: July 17, 2009. Get complete insights and analysis.

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## Details

- Title: Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
- 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: 2009-07-17
- Last Changed: 2025-02-03
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2007-D-0434">FDA-2007-D-0434</a>

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