Home » Lawmakers Seek FDA Review Changes, REMS Assessment in PDUFA Reauthorization
Lawmakers Seek FDA Review Changes, REMS Assessment in PDUFA Reauthorization
Despite more than a year of negotiations between industry and the FDA on reauthorization of the Prescription Drug User Fee Act (PDFUA V), lawmakers are pushing for additional changes to revamp the approval process — a move that could threaten a swift reauthorization.
Drug Industry Daily
Drug Industry Daily
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