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

NME Slump Continues: FDA Clears 18 Novel Drugs In 2006, Same As 2005

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's final approval tally of new molecular entities in 2006 is almost a 25-year low, despite early signs that the agency was on pace to best last year's final count of NME approvals

You may also be interested in...



FDA First-Cycle Approval Rate Is Silver Lining In Cloud Of Low NME Count

Three-quarters of the new molecular entities cleared by FDA in 2007 were approved on the first review cycle, a high for this decade and a positive note to counterbalance the record low number of NMEs approved

FDA First-Cycle Approval Rate Is Silver Lining In Cloud Of Low NME Count

Three-quarters of the new molecular entities cleared by FDA in 2007 were approved on the first review cycle, a high for this decade and a positive note to counterbalance the record low number of NMEs approved

End Of Phase II Meetings Used By Less Than Half The Firms In PwC Survey

Fewer than half of drug companies participating in a PricewaterhouseCoopers survey participated in a meeting with FDA at the conclusion of Phase II studies

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS047924

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