Industry dietary supplement GMP proposal published for comments in ANPR.
This article was originally published in The Tan Sheet
Executive Summary
DIETARY SUPPLEMENT GMPs: "COMPETENT MEDICAL" EVALUATION OF REPORTED ADVERSE EVENTS may be needed to "determine whether follow-up action is necessary to protect the public health," FDA states in an advanced notice of proposed rulemaking on current Good Manufacturing Practice regs for dietary supplements. The notice, published in the Feb. 6 Federal Register, requests comments on an industry proposal for dietary supplement GMPs and a number of related GMP topics, including the appropriate review of adverse event reports. Comments will be accepted by the agency through May 7.
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