Research on Supervision System of Combination Product in FDA.
10.3969/j.issn.1671-7104.2021.06.016
- Author:
Qian DONG
1
;
Meng TIAN
2
;
Ruihong MU
1
Author Information
1. National Institutes for Food and Drug Control, Beijing, 102629.
2. Beijing Northern Hospital of Weaponry Industry, Beijing, 100089.
- Publication Type:Journal Article
- Keywords:
combination product;
drug-device combination product;
supervision system
- MeSH:
Device Approval;
Drug Approval;
United States;
United States Food and Drug Administration
- From:
Chinese Journal of Medical Instrumentation
2021;45(6):670-673
- CountryChina
- Language:Chinese
-
Abstract:
On the basis of introducing FDA's regulatory measure and relevant requirement for life-cycle management of combination product, this paper aims to discuss corresponding countermeasure for supervision system construction in consideration of domestic drug-device combination product's current situation, in order to promote innovative development of relevant industries.
