Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

CDER Dispute Resolution Process Gained Prominence In 2007

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's formal dispute resolution process had a higher profile in 2007 than previous years, suggesting that the rising number of multiple action letters and increasingly vocal criticism of FDA intransigence likely have contributed to the trend of more - or more public - formal appeals

You may also be interested in...



FDA Denies Gilead’s Appeal Of Aztreonam Lysine “Complete Response” Letter

Gilead has not yet discussed with FDA whether ongoing studies will be sufficient for resubmission of the inhaled antibiotic for use by cystic fibrosis patients.

FDA First Cycle Approval Rate Is Silver Lining In Cloud Of Dismal 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 Dismal 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.

Topics

UsernamePublicRestriction

Register

LL043624

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