Skip to main content
U.S. flag

An official website of the United States government

Return to Search

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

Final

Issued by: Food and Drug Administration (FDA)

Issue Date: July 14, 2009

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.