FDA RESEARCH PROGRAM ON CLINICAL TRIAL METHODOLOGY AND ANALYSIS
This article was originally published in The Tan Sheet
Executive Summary
FDA RESEARCH PROGRAM ON CLINICAL TRIAL METHODOLOGY AND ANALYSIS was suggested by new FDA Center for Drug Evaluation & Research Director Janet Woodcock, MD, as a way of "mining" the "vast resource" of unpublished data and data analyses within the agency. In her first public address as CDER director, Woodcock told the Food & Drug Law Institute's Pharmaceutical '94 Update meeting in Washington, D.C. on May 23: "I feel there should be a research program within the FDA on clinical trial methodology and analysis." She also suggested that "some of the goals of these programs could be published and made publicly available."
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