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

US FDA, Advisory Committees Rarely Disagree

Executive Summary

A Milbank Quarterly study and a Pink Sheet analysis show that disagreement between the US FDA and its advisory committee meetings doesn't happen often; it is even rarer for the agency to approve a drug against the advice from a panel.

You may also be interested in...



Aduhelm Approval Firestorm Raises Question: What Are US FDA Advisory Committees For, Anyway?

After three panel members resign over agency’s approval of Biogen’s Alzheimer’s disease drug, the ‘billion-dollar question’ is why FDA provided so little information to justify use of beta amyloid as a surrogate endpoint, one panelist asserts, especially since the agency expressly disavowed the pathway during the advisory committee meeting.

Will Aducanumab Join List Of Drugs Approved By US FDA Over Advisory Committee Opposition?

A look at drugs the agency approved despite an advisory committee vote not to do so and how they compare to Biogen’s Alzheimer’s disease drug aducanumab.

Will A US FDA Advisory Committee Be In Intercept's Future?

There are strong reasons to justify an advisory committee meeting for the NASH application, but also an outlet for the US FDA to skip it.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS125638

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