Prescription Drug User Fee Act (PDUFA) of 1992

In 1992, Congress first enacted the Prescription Drug User Fee Act (PDUFA) which collects fees from drug manufacturers. The FDA uses the additional revenue stream to hire more staff with the goals of:

  1. More efficient and timely review of license applications, and
  2. Increase their medical and scientific expertise.
The law was authorized for five years and has been reauthorized 4 times (PDUFA II, PDUFA III, PDUFA IV and PDUFA V in 2012) and is up for reauthorization again in 2017.

Orphan Drug Act of 1983

111TH CONGRESS

1ST SESSION

H. R. 5238

IN THE HOUSE OF REPRESENTATIVES

December 15, 1981

Mr. Waxman introduced the following bill; which was referred to the Committee on Energy and Commerce

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