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
The "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Hatch-Waxman Amendments, established the approval pathway for generic ...
It is generally believed that the Act accomplished both goals: encouraging development of new medications and accelerating market entry of generics.
Sets special conditions for an application for a product primarily using recombinant DNA technology. Limits the rights derived from a patent during an extension ...
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 ...
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 ...
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 ...
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 enables manufacturers of generic drug prod- ucts to submit their products for approval under an ...