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With more cha-ching, will PDUFA V satisfy on the ba-bling?

 
• By Donna Young

The smooth sailing the Prescription Drug User Fee Act (PDUFA) reauthorization process experienced this past year – with the legislation getting through Congress with rare bipartisan support and little opposition in record time – does not necessarily mean there will be calm waters ahead for the US FDA, which must now follow through on the negotiated commitments it made, albeit with a few dollars more in its pocket and some added authorities and flexibility.

The smooth sailing the Prescription Drug User Fee Act (PDUFA) reauthorization process experienced this past year – with the legislation getting through Congress with rare bipartisan support and little opposition in record time – does not necessarily mean there will be calm waters ahead for the US FDA, which must now follow through on the negotiated commitments it made, albeit with a few dollars more in its pocket and some added authorities and flexibility.

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