FDA REGULATORY ROLE IN INDUSTRY PHARMACOECONOMIC ANALYSES LIMITED, CDER's WOODCOCK SAYS; STANDARDS IN COST EFFECTIVENESS FOR ADS MUST BE CONSISTENT
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.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth