The authorized considerations on the pre-clinical study of drug-eluting coronary stent system.
- Author:
Maobo CHENG
;
Xinli SHI
;
Jianxiong JIA
;
Jingjing MIAO
;
Wei LIU
;
Feilong NIE
- Publication Type:Journal Article
- MeSH:
China;
Drug Evaluation, Preclinical;
methods;
Drug-Eluting Stents;
Guidelines as Topic
- From:
Chinese Journal of Medical Instrumentation
2014;38(6):461-462
- CountryChina
- Language:Chinese
-
Abstract:
China Food and Drug Administration didn't issue any guideline on the pre-clinical study of drug-eluting coronary stent system, the basic requirement of the authorized administration was summarized to help manufacture prepare the document during the registration process.
