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  6. User Fees
  1. History of FDA's Internal Organization

User Fees

User Fees

In 1992, Congress passed the first Prescription Drug User Fee Act (PDUFA), creating a framework to provide external funding for the review of New Drug Applications (NDAs).  By authorizing FDA to collect user fees from manufacturers, PDUFA enabled FDA  to significantly expedite the review of NDAs, and thereby facilitate access to promising new therapies.  Every five years since the passage of PDUFA, Congress is has re-authorized FDA's user fee program, and in the meantime, has also created user fee programs for generic drugs, medical devices, biologics, animal drugs and tobacco products.

The articles in this section offer a detailed analysis of the historical forces that shaped the FDA's user fee programs, and the impact that this funding framework has had on the Agency's functions.