With more cha-ching, will PDUFA V satisfy on the ba-bling?
This article was originally published in Scrip
Executive Summary
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.