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

First Cycle Approval Rate Tops 50% For 2006 NMEs; Merck Hits 100%

Executive Summary

Merck skillfully navigated FDA's approval process in 2006, receiving all five of its new molecular entity and novel biologic approvals after only a single review cycle

You may also be interested in...



User Fee Hike Will Give Sponsors Clarity On Label, Postmarketing Discussions

As part of its recommendations for the renewal of the user fee program, FDA is proposing refinements to its "74-day letters" to give sponsors a more detailed schedule of how the application review will proceed

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

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

First-Cycle Approvals May Rise For Second Consecutive Year – Parexel Report

First-cycle approvals by FDA's Center for Drug Evaluation & Research may continue to rise for a second consecutive year, according to Parexel's Bio/Pharmaceutical R&D Statistical Sourcebook 2006/2007

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS047972

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