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Home » Lawmakers May Tinker With FDA’s Review Process, REMS in PDUFA
Lawmakers May Tinker With FDA’s Review Process, REMS in PDUFA
July 8, 2011
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.