Search results
Results from the WOW.Com Content Network
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests ...
t. e. The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), 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. The Act's two main goals are to facilitate entry of generic drugs into the market and to ...
v. t. e. An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product.
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. The Court held that a defendant, accused of patent ...
The federal government is proposing a new framework that could allow for increased manufacturing of prescription drugs. The Biden Administration’s Plan to Seize Drug Patents, Explained Skip to ...
Orange-Book-Standard, issued in 2009 by the German Federal Court of Justice on the interaction between patent law and standards. Orange Book, a local area networking protocol based on the Cambridge Ring and one of the UK Coloured Book protocols. Handbook of Directives and Permitted Conventions for the English Bridge Union.
In 2006, McAndrews, Held & Malloy partner Aaron F. Barkoff, Ph.D., founded the "Orange Book Blog", which is a respected weblog reporting on new developments in pharmaceutical patent law and FDA law. Barkoff has extensive experience in Abbreviated New Drug Application litigation, from pre-filing investigations and strategy to dispositive motions ...
The Lens, formerly called Patent Lens, is a free searcheable online patent and scholarly literature database, provided by Cambia, an Australia-based non-profit organization. The Lens has been hailed as the “most comprehensive scholarly literature database, that exceeds in its width and depth two leading commercial databases ( Web of Science ...