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Congress Did Not Intend FDAAA Sec. 912 To Apply To Supplements – Industry

This article was originally published in The Tan Sheet

Executive Summary

FDA should not subject dietary supplements to an FDA Amendment Act of 2007 provision that, if interpreted broadly, would block supplement sales, restrict innovation and discourage pre-market safety and efficacy tests, industry leaders say

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Firms should investigate regulatory hurdles and gauge the commercial appeal of a finished product before moving dietary supplement ingredients into the pharmaceutical realm, say manufacturing and testing consultants

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