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FDA’s Jenkins On “Progressive Approval”: Don’t Lower The Efficacy Bar

 
• By Sue Sutter

Office of New Drugs director says a “weight of the evidence” standard will not provide reasonable assurance of drug efficacy and safety.

There are plenty of unknowns surrounding the concept of a “progressive approval” system, but one thing is clear in the eyes of FDA Office of New Drugs Director John Jenkins – there should be no lowering of the efficacy bar.

During a panel discussion at Elsevier Business Intelligence’s FDA/CMS Summit on Dec. 8, Jenkins was asked to comment on proposals...

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