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In summary, PDUFA stays a cornerstone of the present FDA drug overview approach, particularly simply because Congress has shown little interest in growing direct appropriations to your agency. The charges created by PDUFA have authorized the FDA to rent more employees, appreciably boost evaluation moments for medications and biologics, and improve usage of essential therapies for sufferers.
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Each individual PDUFA reauthorization creates a “will have to move” legislative car or truck on which business can aim its Strength and lobbying efforts, which Congress ought to then take into consideration and vote on within a confined time frame, constraining its capability to significantly revise the commitments resulting from FDA-business negotiation.
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