FDA Releases Final Guidance on Serious Adverse Event Reporting

FDA (Rockville, MD) announced in today's Federal Register the release of its final draft of "Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act," according to the American Herbal Products Association (AHPA; Silver Spring, MD).

FDA's final guidance concerns the required submission of written reports to FDA within 15 days by any "responsible person," typically a product marketer, whose product has received report of a serious adverse event. These regulations took full effect in December 2007.

An earlier draft of the guidance was issued in October 2007, and AHPA submitted comments in response to it. The final guidance shows evidence that several of AHPA's comments, including concern with interpretation of official language, were considered and even incorporated into the language of the documents.

FDA's final guidance can be read here: www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm171383.htm

AHPA's 2007 comments can be read here: www.ahpa.org/Portals/0/pdfs/07_1214_AHPAcomments_DS-SAER.pdf

-Robby Gardner