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These are listed in later-enacted Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, commonly known as the Purple Book. [3] The DrugPatentWatch website offers a "Free DrugPatentWatch Orange Book PDF Library" from which the public can download digital copies of every FDA ...
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.
Orange-Book-Standard (Az. KZR 39/06) is a decision issued on May 6, 2009 by the Federal Court of Justice of Germany ( German : Bundesgerichtshof , BGH) on the interaction between patent law and technical standards , and more generally between intellectual property law and competition law .
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The Compendium of Analytical Nomenclature is an IUPAC nomenclature book published by the International Union of Pure and Applied Chemistry (IUPAC) containing internationally accepted definitions for terms in analytical chemistry. [1] It has traditionally been published in an orange cover, hence its informal name, the Orange Book.
Authorities investigating a 26-year-old Buena Park resident discovered a "clandestine drug lab" chock-full of suspected fentanyl pills and other drugs, police announced.
President-elect Donald Trump speaks during a news conference at Mar-a-Lago, on December 16, 2024, in Palm Beach, Florida. (Evan Vucci/AP)
It has traditionally been published in an orange cover, hence its informal name, the Orange Book. Although the book is described as the "Definitive Rules", there have been three editions published; the first in 1978 (ISBN 0-08022-008-8), the second in 1987 (ISBN 0-63201-907-7) and the third in 1998 (ISBN 0-86542-615-5). The third edition is ...