FDA DEADLINE FOR MIFEPRISTONE DECISION IS SEPT. 18; EFFICACY OF MIFEPRISTONE FOR PREGNANCY TERMINATION ESTABLISHED BY TWO FRENCH STUDIES, CMTE. SAYS
Executive Summary
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.