Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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.

Latest Headlines
See All
UsernamePublicRestriction

Register

PS024513

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel