Risk management of drug products in FDA: the development and implication

doi:10.5246/jcps.2015.06.052

Abstract

Abstract:

This paper presented detailed information about the timeline of development of drug risk management in FDA. The time process was divided into three stages: the launch of laws and regulations of drug risk management, pre-market approval and post-market safety supervision, adverse drug reaction and risk communication. To address the problems existing in drug risk management in China, suggestions to further and improve the development of drug risk management are proposed.

Key words: Drug risk management, Drug safety, Drug supervision, FDA

CLC Number:

R951

Supporting:

Baomin Wang, Linguang Zhou, Bin Li, Song Yang, Bin Jiang. Risk management of drug products in FDA: the development and implication[J]. Journal of Chinese Pharmaceutical Sciences, 2015, 24(6): 405-411.

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