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  5. FDA's Legal Authority
  1. Changes in Science, Law and Regulatory Authorities

FDA's Legal Authority

The federal regulation of food, drugs, cosmetics, biologics, medical products and tobacco is legally mandated by acts of the United States Congress.  Since the early-20th century, the laws that establish FDA's regulatory authority have been modified to cover new product areas, expand enforcement powers, provide for new funding sources, modernize surveillance, inspection and investigative methods and enhance public education efforts.   

The articles below offer deeper insight into ways in which legal reforms and case precedent have transformed FDA's regulatory powers through the years:


User Fee Programs

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 article below offers 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:

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