FDA DEADLINE FOR MIFEPRISTONE DECISION IS SEPT. 18; EFFICACY OF MIFEPRISTONE FOR PREGNANCY TERMINATION ESTABLISHED BY TWO FRENCH STUDIES, CMTE. SAYS
FDA intends to act on the NDA for mifepristone (RU-486) for use with misoprostol to terminate pregnancy by the six-month user fee deadline of Sept. 18, Commissioner Kessler said following a positive advisory committee review of the agent.
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