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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:
The GSRS is a freely distributable software system provided through a collaboration between the FDA, the National Center for Advancing Translational Sciences (NCATS) and the European Medicines Agency (EMA). [1] The GSRS was developed to implement the ISO 11238 standard which is one of the core ISO Identification of Medicinal Product (IDMP ...
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.
Those ever-present TV drug ads showing patients hiking, biking or enjoying a day at the beach could soon have a different look: New rules require drugmakers to be clearer and more direct when ...
Drug Manufacturer Indication Crizotinib: PF Prism: ALK-positive systemic anaplastic large cell lymphoma: Trastuzumab deruxtecan: Daiichi Sankyo: HER2-positive gastric or gastroesophageal junction adenocarcinoma, previously treated with trastuzumab: Umbralisib: TG Therapeutics: marginal zone lymphoma, previously treated with an anti-CD20-based ...
A dispute over the U.S. Food and Drug Administration's refusal to let two e-cigarette companies sell flavored vape products due to their health risk to youths goes before the U.S. Supreme Court on ...
Novo Nordisk is lifting curbs on prescriptions of its weight-loss drug Wegovy in the United States and is increasing supply in that market, its CEO said on Wednesday. "In our guidance for the full ...