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

The Greatest FDA Advisory Committees, Part II: The Birth Of The ‘Pazdur Moment’

Executive Summary

With landmark advisory committee meetings coming up, we take a look back at some of the memorable panel meetings over the last 20 years. This is Part II in the series.

You may also be interested in...



Hurry Up and Wait: The Slowdown in Accelerated Approvals

Accelerated approvals are decelerating. Sponsors argue the FDA is so caught up in the current emphasis on safety that they're raising the AA efficacy standards. The FDA contends that the companies who have been rejected aren't meeting the efficacy standards or performing the promised follow-up trials. Is the FDA changing the rules-or are companies themselves bending them? A look at several recent cases of AA therapies reveals that both are true.

Ilex Clolar Advisory Committee Splits On Pediatric Leukemia Approvals

FDA's Oncologic Drugs Advisory Committee recommended accelerated approval for Ilex' Clolar (clofarabine) in the treatment of pediatric acute lymphoblastic leukemia, but not pediatric acute myelogenous leukemia, at its Dec. 1 meeting

Inex/Enzon's Marqibo Not Eligible For Accelerated Approval, Committee Says

Treatments described in literature constitute "available therapy" to treat relapsed, aggressive non-Hodgkin's lymphoma, cmte. says. Partial responses seen in the pivotal trial of the liposomal vincristine treatment are not reasonably likely to predict a clinical benefit, cmte. finds.

Topics

Related Companies

UsernamePublicRestriction

Register

LL1134044

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