Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

Autor:	Garth Boehm, Lixin Yao, Liang Han, Qiang Zheng
Jazyk:	angličtina
Rok vydání:	2013
Předmět:	Generic drugs Drug Price Competition and Patent Term Restoration Act Abbreviated new drug application Bioequivalence Drug quality Generic drug substitution Therapeutics. Pharmacology RM1-950
Zdroj:	Acta Pharmaceutica Sinica B, Vol 3, Iss 5, Pp 297-311 (2013)
Druh dokumentu:	article
ISSN:	2211-3835 2211-3843
DOI:	10.1016/j.apsb.2013.07.004
Popis:	The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.
Databáze:	Directory of Open Access Journals
Externí odkaz:	https://doaj.org/article/0d2193c903f14452a1cafb9c8d7f73ed Zobrazit plný text záznamu View record in DOAJ