Research of Disclosure and Confidentiality of FDA Information in US / 中国药学杂志

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.