The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process.
Read more about Prescription Drug User Fee Act: History, PDUFA Dates, Scale of Fees, FDA Budget
Famous quotes containing the words prescription, drug, user, fee and/or act:
“I am like a doctor. I have written a prescription to help the patient. If the patient doesn’t want all the pills I’ve recommended that’s up to him. But I must warn that next time I will have to come as a surgeon with a knife.”
—Javier Pérez De Cuéllar (b. 1920)
“Behind the steering wheel
The boy took out his own forehead.
His girlfriend’s head was a green bag
Of narcissus stems. “OK you win
But meet me anyway at Cohen’s Drug Store
In 22 minutes.””
—John Ashbery (b. 1927)
“A worker may be the hammer’s master, but the hammer still prevails. A tool knows exactly how it is meant to be handled, while the user of the tool can only have an approximate idea.”
—Milan Kundera (b. 1929)
“I like to be in America!
OK by me in America!
Ev’rything free in America
For a small fee in America!”
—Stephen Sondheim (b. 1930)
“Awareness has changed so that every act for children, every piece of legislation recognizes that children are part of families and that it is within families that children grow and thrive—or don’t.”
—Bernice Weissbourd (20th century)