Pediatric Research

• BIO Letter of Support for H.R. 2857, the Pediatric Research Equity Act of 2003 (Sep. 17, 2003)
• Court Decision Invalidating FDA's Pediatric Rule (Nov. 14, 2002)
• History of Pediatric Studies, Rule, Legislation and Litigation (Jan. 8, 2002)

PDUFA: Prescription Drug User Fee Act
The Prescription Drug User Fee Act (PDUFA), first enacted in 1992 and revised in 1997, is a program under which the pharmaceutical/biotechnology industry pays certain "user fees" to the Food and Drug Administration (FDA). In exchange for these fees, the FDA agreed, via correspondence with Congress, to a set of performance standards intended to reduce the approval time for New Drug Applications (NDA) and Biological License Applications (BLA).
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First Amendment Request for Comment (559 KB Printable PDF)