Washington: PDUFA fees announced

WASHINGTON - The FDA announced rates for the three types of prescription drug user fees it is permitted to collect in the government's fiscal 1998 that began in October.

Under the Prescription Drug User Fee Act (PDUFA), as amended by the recently enacted FDA modernization legislation, one-third of the total user fee revenue each year must come from each of the three types of fees covered by the statute. The fees cover applications for approval of drug and biological products; establishments where the products are made; and upon the approved products themselves...