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引用次数: 0
摘要
理想的治疗方法具有低毒性,并能有效地控制病情或疾病。美国食品和药物管理局(FDA)销售的治疗类药物被称为“医疗食品”(MFs),符合这样的定义。自1988年通过《孤儿药法案》(Orphan Drug Act)以来,医疗食品就一直存在于联邦法律中,该法案创建了一个与药物分开的营养疗法类别。不幸的是,由于缺乏fda批准程序,缺乏不明确和相互矛盾的指导,特别是在研究性新药(IND)申请方面的需要,以及没有明确的关于其开发和营销的规定,MFs并没有被医学界广泛理解,也没有被所有需要它们的患者使用。本文的目标是提出“最佳实践”,以指导医疗食品行业的产品开发和营销,并作为FDA进一步监管建议的起点,以便证明通常被认为是安全的治疗方法(GRAS)。提供食物成分,以满足特定病症/疾病的独特营养需求,并被证明对该病症/疾病的管理有效,可用于使需要它们的患者受益。
Proposed Industry Best Practices in Development and Marketing of Medical Foods for the Management of Chronic Conditions and Diseases while Awaiting Regulation.
Ideal therapeutics have low toxicity and can effectively manage condition(s) or disease(s). The Food & Drug Administration (FDA) marketing category of therapeutics called “medical foods” (MFs) meets such a definition. Medical foods have existed in Federal law since passage the Orphan Drug Act in 1988, which created a category of nutritional therapeutics separate from drugs. Unfortunately, MFs are not widely understood by the medical community or utilized in all patients who need them due to lack of a FDA-approval process, unclear and contradictory guidance especially with regard for need for an investigational new drug (IND) application, and no clear regulations regarding their development and marketing. The goals of this article are to propose “Best Practices” to guide the medical food industry in the development and marketing of products as well as to serve as a starting point for suggestions regarding further FDA regulation so that therapeutics which are shown to be generally recognized as safe (GRAS), provide food ingredients to meet a distinctive nutritional requirement for a specific condition/disease and are proven effective for the management for that condition/disease can be used to benefit patients who need them.
期刊介绍:
The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products.
Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law.
All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.