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Senate FDA reform negotiations stuck on national uniformity, inspection authority issues.

This article was originally published in The Tan Sheet

Executive Summary

FDA REFORM SENATE NEGOTIATIONS CONTINUE: RECORD-KEEPING inspection authority is one of a handful of issues keeping the FDA Modernization & Accountability Act of 1997 (S 830) from reaching the Senate floor for debate. FDA and industry, including representatives from the Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry & Fragrance Association, reached a tentative agreement July 29 that would keep some of FDA's record-keeping inspection authority for OTCs parallel to that for prescription drugs.
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