Pink Sheet is part of the Informa Intelligence Division 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


Small Companies Turning To CDER Ombudsman For Help With Drug Approvals

This article was originally published in The Pink Sheet Daily

Executive Summary

While the CDER ombudsman dealt with far fewer complaints overall in 2011 than in 2010 due to administrative changes, smaller companies are increasingly asking for help in certain key areas of drug development.


Related Content

FDA Sponsor Liaison Program Is Not Being Used: Are Small Biotechs Missing An Opportunity? Or Partnering More?
Calling The Ombudsman: Contacts With ANDA Sponsors, Investors On The Upswing
FDA Dispute Resolution Process Invoked About 10 Times Annually
An Emerging Approval Trend At FDA: More First-Time Sponsors
Emerging Sponsors And FDA: Will Better Communication Under PDUFA V Ease Inherent Tensions?
"Bad Ad" Program Set To Expand After Opening Spigot Of Complaints In Year One
Complaints To CDER Down, But Lorcaserin Weighs Heavily At Ombudsman's Office


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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