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)
“Narcotics have been systematically scapegoated and demonized. The idea that anyone can use drugs and escape a horrible fate is an anathema to these idiots. I predict that in the near future, right wingers will use drug hysteria as a pretext to set up an international police apparatus.”
—Gus Van Sant, U.S. screenwriter and director, and Dan Yost. Father Tom Murphy (William S. Burroughs)
“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)
“The ambivalence of writing is such that it can be considered both an act and an interpretive process that follows after an act with which it cannot coincide. As such, it both affirms and denies its own nature.”
—Paul De Man (1919–1983)