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
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: