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Despite Gottlieb's call for a rethinking of FDA trial policy . . .

Woodcock: Throwing Out International Clinical Trial Standards Not An Option

October 06, 2017
Coming as FDA Commissioner Scott Gottlieb pushes to reform the clinical trial process, drug center chief Janet Woodcock rebuffed arguments by some that regulators should eliminate existing global consensus regulations on trial practices because they increase drug development costs. Woodcock contended that while more flexibility is important, guidelines are necessary to protect against those seeking to abuse the system. The discussion was part of a recent real-world evidence public workshop held at the National Academies of Sciences, Engineering, and Medicine...


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