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).
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning