Speed, safety, and industry funding - from PDUFA I to PDUFA VI

New England Journal of Medicine

7 December 2017 - The FDA Reauthorization Act of 2017 includes the sixth version of the Prescription Drug User Fee Act. 

User fees have accelerated drug approvals in the context of inadequate funding of the FDA, and industry now pays 75% of the costs of the scientific review of drugs.

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Michael Wonder

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Michael Wonder