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

GAO Questions FDA's Handling Of Surrogate Endpoints

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA should develop guidance delineating when it would withdraw products that have been cleared under the accelerated approval mechanism, according to a report from the Government Accountability Office

You may also be interested in...



Postmarketing Studies Face Continued Scrutiny Despite Cleaned-Up Database

Drug makers that have put off starting post-market studies under FDA oversight can no longer count on the agency's messy database to provide cover for their dawdling

FDA Changes Its Mind On Vytorin; Ads Must Note “Efficacy Limitation”

One of the more interesting revelations from the House Energy and Commerce Committee's investigation into the ENHANCE trial is a document that may help explain why the Vytorin TV ads were pulled - and how FDA is handling questions about product efficacy in the current environment

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

Topics

UsernamePublicRestriction

Register

LL1133546

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