Prescription Drug User Fee Act

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 others—first 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 one’s own interests and desires. Carried to its “perfection,” it produces the martyr syndrome or the smothering wife and mother.
    Jean Baker Miller (20th century)

    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)

    As a general rule never take your whole fee in advance, nor any more than a small retainer. When fully paid beforehand, you are more than a common mortal if you can feel the same interest in the case, as if something was still in prospect for you, as well as for your client.
    Abraham Lincoln (1809–1865)

    It is in the very nature of things human that every act that has once made its appearance and has been recorded in the history of mankind stays with mankind as a potentiality long after its actuality has become a thing of the past.
    Hannah Arendt (1906–1975)