High Quality Content by WIKIPEDIA articles! The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act", is a 1984 United States federal law which established the modern system of generic drugs. The informal name comes from the Act's two sponsors, representative Henry Waxman of California and senator Orrin Hatch of Utah. Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505 21 U.S.C. 355 sets forth the process by which would-be marketers of generic drugs can file Abbreviated New Drug Applications to seek FDA approval of the generic.

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