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:
“Women are taught that their main goal in life is to serve othersfirst men, and later, children. This prescription leads to enormous problems, for it is supposed to be carried out as if women did not have needs of their own, as if one could serve others without simultaneously attending to ones own interests and desires. Carried to its perfection, it produces the martyr syndrome or the smothering wife and mother.”
—Jean Baker Miller (20th century)
“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 (18891963)
“A worker may be the hammers 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)
“..for a prostitutes fee is only a loaf of bread, but the wife of another stalks a mans very life.”
—Bible: Hebrew, Proverbs 6:26.
“Dont be so ready to defy everybody. Act as if you expected to have your own way, not as if you expected to be ordered about. The way to get on as a lady is the same as the way to get on as a servant: youve got to know your place.”
—George Bernard Shaw (18561950)