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

Skipping the Advisory Committee, but Getting the Advice

This article was originally published in RPM Report

Executive Summary

Pfizer’s Xalkori sailed through FDA without an advisory committee review. But FDA did consult with two outside advisors--including the Oncology Committee Chair--along the way.

You may also be interested in...



FDA Outlines “Expedited” Review For Breakthrough Therapies; “Hyper-Fast” Reviews, Beyond Oncology

Oncology drug sponsors have gotten used to a “faster-than-Priority” timeline for breakthrough products. Now, FDA is outlining a formal process for its reviewers to use for any “Breakthrough” designated therapy with life-saving potential.

FDA’s First “Program” Reviews: Fast Approvals, But Still Some Surprises

The Food & Drug Administration is approving the first products under the new PDUVA V review process. The Program, as it is known, gives FDA an extra two months with an application in exchange for additional meetings for sponsors. It’s designed to help reduce the number of late-cycle “surprises.” There have been a few hiccups, but so far, it appears to be doing just that.

Biotech Stocks and Advisory Committees: No News Is Good News?

FDA has approved six new molecules already in 2012--and five were approved without going to an advisory committee. Meanwhile, FDA has held four advisory committees to review new drug applications, and all four ended in overwhelming "no" votes.

Related Content

UsernamePublicRestriction

Register

PS080897

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