title: [Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].
abstract: The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. chibjyy@163.com
authors.forename: Yuanyuan
authors.initials: Y
authors.lastname: Li
authors.forename: Yanming
authors.initials: Y
authors.lastname: Xie
mesh_terms: D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug; D008516:Medicine, Chinese Traditional / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D012308:Risk Management / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration