Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs

F. J. Sasinowski
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引用次数: 77

Abstract

One of the key underlying issues facing the development of effective for their intended uses. all drugs, and particularly orphan drugs, is what kind of evidence the Food and Drug Administration (FDA) requires for FDA has for many decades acknowledged that there is a need approval. The Federal Food, Drug, and Cosmetic [FD&C] Act provides that for FDA to grant approval for a new drug, there ample, one of FDA’s regulations states that: “FDA will apmust be “substantial evidence” of effectiveness derived from prove an application after it determines that the drug meets the “adequate and well-controlled investigations.” This language, statutory standards for safety and effectiveness... While the which dates from 1962, provides leeway for FDA medical restatutory standards apply to all drugs, the many kinds of drugs viewers to make judgments as to what constitutes “substantial that are subject to the statutory standards and the wide range -
FDA批准孤儿药的有效性证据量
发展所面临的关键根本问题之一是有效地为其预定用途。所有的药物,尤其是孤儿药,是食品和药物管理局(FDA)需要什么样的证据,因为FDA几十年来一直承认有必要批准。联邦食品、药品和化妆品法案(FD&C)规定,FDA要批准一种新药,有足够的,FDA的一项规定是:“FDA将在确定该药物符合“充分和良好控制的调查”后,批准来自证明申请的有效性的“实质性证据”。”这种语言,安全和有效性的法定标准…虽然该法案始于1962年,为FDA的医疗修订标准适用于所有药物提供了余地,但许多种类的药物查看者要对什么构成“实质性”做出判断,这是受法定标准和广泛范围的约束的
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