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

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  • Date: May 04, 2012

Non-prescription (OTC) drugs marketed without an approved application are also subject to adverse event reporting requirements, under section 760 of the Federal Food, Drug, and Cosmetic Act. A report of each adverse drug experience which is both serious and unexpected must be made to the Agency, as soon as possible, but no later than 15 days, after receiving information about the event.

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