Introduction of radiopharmaceutical administration policy of FDA
10.3760/cma.j.issn.2095-2848.2018.12.009
- VernacularTitle:美国FDA放射性药物管理体系简介
- Author:
Liqun HUANG
1
;
Wenli XU
;
Jingjing YIN
;
Shufang LI
;
Weibin LI
;
Jianhua WEN
;
Quan AN
Author Information
1. 中国辐射防护研究院放射医学与环境医学研究所、药物毒理与放射损伤药物山西省重点实验室
- Keywords:
Radiopharmaceuticals;
United States Food and Drug Administration;
Drug and narcotic control;
Trends
- From:
Chinese Journal of Nuclear Medicine and Molecular Imaging
2018;38(12):810-812
- CountryChina
- Language:Chinese
-
Abstract:
Radiopharmaceuticals have been widely used in the diagnosis, treatment and monitoring of diseases, and they play an important role in new drug development. Food and Drug Administration(FDA) has rich experience in the administration of radiopharmaceuticals. This article mainly interprets the regulato-ry policy of FDA for radiopharmaceuticals from the aspects of definition, regulations and registration, trying to provide reference for domestic research of radiopharmaceuticals.
