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

Issue Date: July 17, 2009
Issued by: Center for Drug Evaluation and Research
Topic(s): Over-the-Counter Drugs
Status: Final

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

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.

Download the Guidance Document