Drug Price Competition and Patent Term Restoration Act
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The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States. The Act's two main goals are to facilitate entry of generic drugs into the market and to compensate the original drug developers for regulatory delays by the Food and Drug Administration. It is generally believed that the Act accomplished both goals: encouraging development of new medications and accelerating market entry of generics.[1]
Long title | An Act to amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new drug applications, to amend title 35, United States Code, to authorize the extension of the patents for certain regulated products, and for other purposes. |
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Acronyms (colloquial) | Hatch-Waxman amendments |
Enacted by | the 98th United States Congress |
Effective | September 24, 1984 |
Citations | |
Public law | 98-417 |
Statutes at Large | 98 Stat. 1585 |
Codification | |
Acts amended | Federal Food, Drug, and Cosmetic Act |
Titles amended | 21 U.S.C.: Food and Drugs |
U.S.C. sections amended |
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Legislative history | |
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Representative Henry Waxman of California and Senator Orrin Hatch of Utah sponsored the act.