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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 for new approval pathways that would speed the development and market availability of novel therapies. One such proposal is contained in legislation drafted by Sen. Kay Hagan, D.-N.C

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