保健品不是不归FDA管——除了药物之外FDA也管食品安全——只不过食品安全的管理是事后追诉不是事前审批。
根据《膳食补充剂保健与教育法》（Dietary.Supplement.Health.and.Education.Act，简称DSHEA）定义，“膳食...
FDAdoes notapprovestructure-function claims on dietary supplements andother foods. (Is It Really FDA Approved?) Misuse of FDA's logo may violate federal law. 所以,如果有产品声称经美国FDA认证一般都是违法行为。 如果有dietary supplement声称经美国FDA批准也是违法行为。 国内方面,CFDA目前对于所辖行业的产...
• FDA-approved biosimilars and interchangeable biosimilars are highly similar versions of FDA-approved reference products.• Biosimilars and interchangeable biosimilars are as safe and effective as the reference product.• Some biosimilars are approved as "interchangeable biosimilars."• Health ca...
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Purple Book (database of FDA-licensed (approved) biological products, including biosimilar and interchangeable products) 紫皮书(FDA许可(批准)的生物制品数据库) 2020.3.23 FDA将生物制品从橙皮书中移除,并为其单独成立了紫皮书板块,这一板块作为较新的版块,收录了细胞、血液、基...
The guidance is titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” Importantly, this guidance applies only to communications about an “unapproved use of an app...
health perspective because it creates a misleading impression regarding the overall safety of Vivitrol. Opioid dependence and misuse is a significant public health concern and a national crisis that impacts millions of lives in the United States. When used as provided in the FDAapproved product ...
─ Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products (June 2021) ─ 已批准申报的CMC 变更:特定生物制品,202106 FDA于2021年6月21日发布了最终指南,帮助某些获得许可的生物产品的申请者来确定批准生物制品许可申请(BLA)在化学、生产和控制(CMC)信息方面变更的...
经过治疗等效性评估的获批药品(Approved Drug Products with Therapeutic Equivalence Evaluations,俗称“橙皮书”)[12]将药学等价药品定义为药物含有相同量的相同活性成分,有相同的剂型、通过相同的给药途径给药。如果已批准的仿制药是已证明BE的药学等效品,并且可以完全...