New FDA User Fee Law includes unheralded but important provisions (and lots and lots of acronyms)

摘要

The passage of the FDA Safety and Innovation Act (FDASIA)1 on 9 July 2012, ushered in a number of new provisions of importance to the pharmaceutical industry. For example, the new law reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time and the Medical Device User Fee Act (MDUFA) for the third time. However, the FDASIA also includes provisions for two entirely new sets of fees, as well as a provision related to new market exclusivity for certain antibiotics. The following is a summary of a few provisions included in the FDASIA that are new and may have been overlooked in the acronymsoup headlines for PDUFA and MDUFA.