POPULATION COUNCIL's RU 486 NDA SUBMISSION EXPECTED WITHIN 16 MONTHS
Executive Summary
POPULATION COUNCIL's RU 486 NDA SUBMISSION EXPECTED WITHIN 16 MONTHS, FDA Commissioner Kessler testified at a May 16 hearing before Rep. Wyden's (D-Ore.) House Small Business/Regulation Subcommittee. "We have been told by the Population Council that they anticipate that [an] application will take between nine and 16 months to prepare," Kessler said. In a press conference preceding the hearing, HHS Secretary Shalala announced that Roussel Uclaf is donating its U.S. patent rights to the abortifacient RU 486 (mifepristone) to the New York City-based non-profit research organization.