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

FDA Post-Marketing Clinical Trial Authority Should Be Bolstered, Topol Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Cleveland Clinic researcher Topol's suggestion is part of a JAMA editorial critical of COX-2s following Pfizer's announcement that Celebrex demonstrated an increased cardiovascular risk in a cancer trial. Topol advocates for second-line use and a contraindication in high-risk patients.

You may also be interested in...



Pfizer Celebrex Polyp Trial Shows Increase In Cardiovascular Events

The Adenoma Prevention with Celecoxib trial found an increased CV risk for patients taking 400 mg and 800 mg Celebrex compared to placebo; a second study showed no increased risk. The APC study results mean Pfizer can no longer promote the COX-2 as being clear of cardiovascular signals.

Sen. Grassley Plans Legislation On Independence Of FDA Drug Safety Office

Finance Committee chair acknowledges he does not have enough votes for such legislation but says he is starting the "process of educating my colleagues" and "intends to continue that until we get this job done." Grassley's requested GAO report on the Office of Drug Safety will take several months.

Able Unable To Reform On Its Own? Firm Seeks Consent Decree To Address Manufacturing Issues

“We are prepared to enter discussions toward a decree at FDA’s earliest convenience,” Able says in letter to FDA. Company is pursuing consent decree instead of responding to FDA Form 483 report citing manufacturing deficiencies. The letter follows CEO Maury’s resignation the previous day.

Topics

UsernamePublicRestriction

Register

PS058483

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