FDA REGULATORY ROLE IN INDUSTRY PHARMACOECONOMIC ANALYSES LIMITED, CDER's WOODCOCK SAYS; STANDARDS IN COST EFFECTIVENESS FOR ADS MUST BE CONSISTENT
Executive Summary
FDA should play a limited role in regulating pharmacoeconomic comparative studies, FDA Center for Drug Evaluation & Research Director Janet Woodcock, MD, told an FDA-sponsored conference entitled "Comparing Treatments: Safety, Effectiveness and Cost-Effectiveness" March 23 in Bethesda, Md.