Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Pro

• Date: November 03, 2009
• Source: www.fda.gov

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an ApprovedApplication.’’Thisdocumentprovides guidance to industry on postmarketing serious adverse event reporting for nonprescription (over-thecounter (OTC)) human drugs marketed without an approved application. It gives guidance on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports. Separate guidance, issued by FDA’s Center for Food Safety and Applied Nutrition on adverse event reporting for dietary supplements, is announced elsewhere in this issue of the Federal Register .

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