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)
“Most people aren’t appreciated enough, and the bravest things we do in our lives are usually known only to ourselves. No one throws ticker tape on the man who chose to be faithful to his wife, on the lawyer who didn’t take the drug money, or the daughter who held her tongue again and again. All this anonymous heroism.”
—Peggy Noonan (b. 1950)
“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)
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—Stephen Sondheim (b. 1930)
“We must not suppose that, because a man is a rational animal, he will, therefore, always act rationally; or, because he has such or such a predominant passion, that he will act invariably and consequentially in pursuit of it. No, we are complicated machines; and though we have one main spring that gives motion to the whole, we have an infinity of little wheels, which, in their turns, retard, precipitate, and sometime stop that motion.”
—Philip Dormer Stanhope, 4th Earl Chesterfield (1694–1773)