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Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), (H.R. 2, Pub. L. 114–10 (text)) commonly called the Permanent Doc Fix, is a United States statute. Revising the Balanced Budget Act of 1997 , the Bipartisan Act was the largest scale change to the American health care system following the Affordable Care Act in 2010.
According to a reference glossary provided by the United States Senate, an authorization act is "A law that establishes or continues one or more Federal agencies or programs, establishes the terms and conditions under which they operate, authorizes the enactment of appropriations, and specifies how appropriated funds are to be used.
Drug Price Competition and Patent Term Restoration Act; 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. Acronyms (colloquial)
This is a list of legal terms relating to patents and patent law.A patent is not a right to practice or use the invention claimed therein, but a territorial right to exclude others from commercially exploiting the invention, granted to an inventor or their successor in rights in exchange to a public disclosure of the invention.
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
The original patent term under the 1790 Patent Act was decided individually for each patent, but "not exceeding fourteen years". The 1836 Patent Act (5 Stat. 117, 119, 5) provided (in addition to the fourteen-year term) an extension "for the term of seven years from and after the expiration of the first term" in certain circumstances, when the inventor hasn't got "a reasonable remuneration for ...
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
Under Section 287(c) of the Patent Act, however, a claim of patent infringement cannot be maintained against a medical practitioner for performing a medical activity, or against a related health care entity with respect to such medical activity, unless the medical practitioner is working in a clinical diagnostic laboratory. [44]