BURLINGTON ARGUES FOR FDA "DISCRETION" IN MAKING REFORMS RATHER THAN "PRESCRIPTIVE" LEGISLATION; CDRHer CRITICIZES EFFORTS TO "GUT" EFFICACY STANDARD
This article was originally published in The Gray Sheet
Executive Summary
FDA reform efforts in Congress should provide the agency wide latitude in making internal changes necessary to carry out its mission rather than spelling out "prescriptive" requirements, Center for Devices and Radiological Health Director Bruce Burlington said Dec. 13 at the Food and Drug Law Institute's Educational Conference in Washington, D.C.