FDA to Collect $1.2 Billion in User Fees

August 1, 2002

WASHINGTON-President Bush has signed legislation that reauthorizes the Prescription Drug User Fee Act (PDUFA), first enacted in 1992 to speed up the FDA’s processing of new drug applications. PDUFA III is the second 5-year

WASHINGTON—President Bush has signed legislation that reauthorizes thePrescription Drug User Fee Act (PDUFA), first enacted in 1992 to speed up theFDA’s processing of new drug applications. PDUFA III is the second 5-yearextension. It authorizes collection of $1.2 billion in user fees in the next 5years from companies submitting NDAs.