July 16, 2009
FDA: Industry Guidance on Adverse Event Reporting for Dietary Supplements
From the Introduction:
This document provides guidance to the dietary supplement industry for complying with the adverse event reporting and recordkeeping requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462, 120 Stat. 3469). As required by section 3(d)(3) of this law, we are issuing guidance to describe the minimum data elements for serious adverse event reports for dietary supplements. We are also providing guidance on (1) how, when, and where to submit a serious adverse event report for a dietary supplement; and (2) records maintenance and access for serious and non-serious adverse event reports and related documents. A separate guidance has been issued on the reporting of serious adverse events for over-the-counter (nonprescription) human drug products marketed without an approved application.
An article summarizing the guidance is available on nutraingredients-usa.com.
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