October 2007

FDA publishes draft guidance on AERs

The Food and Drug Administration (FDA) published the draft guidance describing the minimum data elements for serious adverse event reports for dietary supplements Oct. 15.

The publication of this guidance fulfills a portion of FDA’s requirement under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which goes into effect Dec. 22. The agency stated this document will provide guidance on how, when, and where to submit a serious adverse event report for a dietary supplement, as well as on records maintenance and access for serious and nonserious adverse event reports and related documents.

The agency also disclosed it is preparing a separate guidance on the reporting of serious adverse events associated with nonprescription human drug products, which also were affected by legislation passed by the U.S. Congress last year. As is standard for the issuance of such guidance, there will be a 60-day period during which comments may be submitted.

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