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GUIDANCE DOCUMENT

Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application July 2009

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2007-D-0434
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This document provides guidance to industry on postmarketing serious adverse event reporting for nonprescription (over-the-counter (OTC)) human drug products marketed without an approved application. In particular, this document gives guidance on (1) the minimum data elements that should be included in a serious adverse event report, (2) the label that should be included with the report, (3) reporting formats for paper and electronic submissions, and (4) how and where to submit the reports.
 

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All written comments should be identified with this document's docket number: FDA-2007-D-0434.

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