The Drug Price Competition and Patent Term Restoration Act - better known as the Hatch-Waxman Act, is a comprehensive legal framework enacted by Congress in 1984 to streamline the process for generic pharmaceutical approvals and preserve incentives for innovation, including the creation of a procedure for patient ...
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Drug Price Competition and Patent Term Restoration Act
The Drug Price Competition and Patent Term Restoration Act, 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. Wikipedia
Acts amended: Federal Food, Drug, and Cosmetic Act
Effective: September 24, 1984
Enacted by: the 98th United States Congress
Public law: 98-417
U.S.C. sections amended: 21 U.S.C. ch. 9 § 301; 21 U.S.C. ch. 9, subch. V §§ 355 & 360cc
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The "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Hatch-Waxman Amendments, established the approval pathway for generic ...
Sets special conditions for an application for a product primarily using recombinant DNA technology. Limits the rights derived from a patent during an extension ...
It is generally believed that the Act accomplished both goals: encouraging development of new medications and accelerating market entry of generics.
Sep 24, 1984 · be cited as the "Drug Price Competition and Patent Term Restora- tion Act of 1984". TITLE I—ABBREVIATED NEW DRUG APPLICATIONS. SEC. 101 ...
Dec 16, 2020 · High prices for branded medicines are one consequence of the Drug Price Competition and Patent Term Restoration Act of 1984, better known as the ...
On September 24, 1984, President Reagan signed the Drug Price Competition and Patent Term Restoration Act (Public Law 98-417) into law. This Act has been ...
The Drug Price Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Act, is a comprehensive legal framework enacted by Congress in 1984 ...
Feb 4, 2020 · Title II of the Act created a program whereby patent holders whose patents claim a human drug product, medical device, food additive or color ...
The Drug Price Competition and Patent Term Restoration Act enables manufacturers of generic drug prod- ucts to submit their products for approval under an ...