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...
Makena Sponsor Covis Seeks To Use FDA Officials’ Words, Actions On Accelerated Approval Against CDER
Company cites comments by Oncology Center of Excellence Director Richard Pazdur and Office of Neuroscience Director Billy Dunn on reasons why confirmatory trials fail and the need for regulatory flexibility. Ironically, both senior officials have publicly extracted commitments from companies to withdraw products if postmarketing trials do not verify clinical benefit.
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