Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Will US FDA Advisory Committees Rebound In 2023?

Executive Summary

The US FDA’s use of outside expert advisory committees rebounded from historic lows in 2022 – but just barely. Will Commissioner Califf’s ‘update’ of the process finally mean more committee meetings in 2023?

You may also be interested in...



The Return Of The Advisory Committee: US FDA Has Busy Fall Ahead

The prototypical US FDA advisory committee review of a pending new drug application has become something of an endangered species. A suddenly busy October and November agenda suggests that might be changing.

Second Time’s The Charm: Amylyx’s ALS Drug Wins US FDA Panel Nod

In switching their votes from the first panel review in March, advisory committee members cited supportive additional analyses of a survival benefit, framing of the issues in the context of unmet need and regulatory flexibility, and the company’s statement that it would withdraw AMX0035 if the Phase III PHOENIX trial does not succeed.

US FDA Advisory Committee ‘Update’ May Result In More Meetings – And More Re-Reviews

Commissioner Robert Califf’s comments offer further context for FDA’s unprecedented decision to reconvene an advisory committee for a second review of Amylyx’ AMX0035 for ALS.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147553

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