Research of Disclosure and Confidentiality of FDA Information in US
CHEN Jia-yin, YANG Yue*
School of Business Administration, Shenyang Pharmaceutical University,International Food and Drug Policy and Law Research Center, Shenyang Pharmaceutical University, Shenyang 110016, China
Abstract��OBJECTIVE To study the content and mechanism of the US Food and Drug Administration (FDA)in balancing information disclosure and confidentiality, and make recommendations for China. METHODS The design and mechanism of information disclosure and confidentiality balance system has been explored from the development of FDA information disclosure and confidentiality. RESULTS The United States has a strict legal and regulatory system. New drug application has series measures to ensure FDA balance information between disclosure and confidentiality, such as active disclosure, request for information and non-public information, FDA IT system security plan, CDER expert network information disclosure, review and confirming of confidentiality provisions in FDA published articles or public speeches. CONCLUSION It is suggested that China introduce the information disclosure and confidentiality clause in upper law, establish information disclosure procedure, and adopt internal information security measures.
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CHEN Jia-yin, YANG Yue. Research of Disclosure and Confidentiality of FDA Information in US. Chinese Pharmaceutical Journal, 2019, 54(1): 66-71.
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2019, Vol. 54 
