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.