FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints

Crosse, Marcia
October 2009
GAO Reports;10/26/2009, preceding p1
Government Documents
The article focuses on a study by the U.S. Government Accountability Office (GAO) on approved drug applications based on surrogate endpoints under Food and Drug Administration's (FDA) accelerated and traditional approval process and the FDA's oversight of postmarketing studies. FDA is recommended by GAO to clarify conditions when it comes to expediting the withdrawal of drugs approved based on surrogate endpoints. GAO believes that this recommendation will enhance FDA's oversight.


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