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FDA will improve administrative record-keeping following Rogaine case -- lawyer predicts.

This article was originally published in The Tan Sheet

Executive Summary

FDA SHORTCOMINGS IN COMPILING ADMINISTRATIVE RECORD FOR ROGAINE CASE will "force" the agency to be more thorough in maintaining its records, Jeffrey Gibbs (of Washington, D.C.-based law firm Hyman, Phelps & McNamara) predicted at a July 23 "briefing" sponsored by the Regulatory Affairs Professionals Society. FDA's administrative record was criticized harshly by Federal Court Judge Robert Holmes Bell in his April 30 decision upholding the agency's denial of Waxman-Hatch exclusivity for Pharmacia & Upjohn's OTC Rogaine ("The Tan Sheet" May 6, p. 1).
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