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


Complete Response Letters: Firms See Value In Public Release, Don't Expect It Will Happen

Executive Summary

One industry CEO says it would on net be beneficial even though some companies would suffer if they were made public.


Related Content

US FDA Wants Authority To Mandate Minor Post-Approval Quality Changes
Complete Response Letters: US FDA Trying To Identify Subsets For Public Release
2017 Complete Response Letters: Fewer Than 2016, Still More Than Years Past
Public Complete Response Letters? Don’t Hold Your Breath
Q&A With US FDA Commissioner Scott Gottlieb
Mapping US FDA's Biosimilar Pathway With Pink Sheet Drug Review Profiles
Gottlieb Q&A: Confirmation Is Nearing, Will Complete Response Letters Finally Get Released?
Oral History Of Drug Development: FDA’s Califf Wants Woodcock, Temple To Share Their Stories
FDA Talking To Industry About Releasing “Complete Response” Letters
“Emerging Sponsors” Pose Regulatory, Public Relations Challenges For Drug Review Process, FDA’s Jenkins Says


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