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)
“If an addict who has been completely cured starts smoking again he no longer experiences the discomfort of his first addiction. There exists, therefore, outside alkaloids and habit, a sense for opium, an intangible habit which lives on, despite the recasting of the organism.... The dead drug leaves a ghost behind. At certain hours it haunts the house.”
—Jean Cocteau (1889–1963)
“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)
“You see what happens today. Women act like men and want to be treated like women.”
—Alan Jay Lerner (1918–1986)