FDARA (Includes PDUFA VI) Signed Into Law

“FDARA reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) for the first time – allowing FDA to continue to collect medical product user fees through fiscal year 2022.” Click here for the full story or here for help with your next Pre-IND Briefing Package.