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

Lost in Translation: Interpreting Advisory Committees

This article was originally published in RPM Report

Executive Summary

FDA's advisory committee process has long been criticized for conflict of interest issues. But now those on the inside are questioning whether change is needed. At the same time, some FDA officials don't believe advisory committees add much to the review process. And given resource constraints, FDA is holding committees less and less often. That may be good news for drug sponsors. The public disclosure of an NDA as part of the committee process leaves sponsors vulnerable to attacks that can undermine the future of a drug. Given the sway advisory committees in the court of public opinion, a re-examination of the system is coming.
Advertisement

Related Content

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS080035

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

Cancel