全球智库信息集成服务系统(G2TT): Generics substitution, equivalence standards, and international oversight: Complex issues facing the FDA

G2TT

来源类型	Article
规范类型	评论
	Generics substitution, equivalence standards, and international oversight: Complex issues facing the FDA
	Roger Bate; Aparna Mathur; Dinesh Thakur
发表日期	2015-12-14
出版年	2015
语种	英语
摘要	Abstract: The regulations for assessing the quality of generic drugs and their bioequivalence to innovator products are outdated and need to be substantially modernized. There are multiple reasons why these changes are needed, including: (i) the regulations remain largely unchanged since the passage of the Hatch–Waxman Act in 1984; (ii) medication therapies have become substantially more complex over the three decades since the passage of the Act; (iii) a switch from an innovator drug to a generic drug, or switching from one generic to another, is not a benign process – there is substantial clinical professional judgment involved and in some instances these decisions should be better informed; and (iv) pharmaceutical ingredients for finished products, whether innovator or generic, are from multiple sources of supply, adding variability in their production, and which may not be accounted for in specification tolerances. When these elements are viewed together, they clearly suggest that more transparency of responsible manufacturers in product labels and updated standards for bioequivalence are required. For subscribers to Trends in Pharmacological Sciences, the paper is available here.
主题	Economics ; Public Economics
标签	drug industry ; FDA ; generic drugs ; Pharmaceuticals
URL	https://www.aei.org/articles/generics-substitution-equivalence-standards-and-international-oversight-complex-issues-facing-the-fda/
来源智库	American Enterprise Institute (United States)
资源类型	智库出版物
条目标识符	http://119.78.100.153/handle/2XGU8XDN/259795
推荐引用方式 GB/T 7714	Roger Bate,Aparna Mathur,Dinesh Thakur. Generics substitution, equivalence standards, and international oversight: Complex issues facing the FDA. 2015.