Research of Disclosure and Confidentiality of FDA Information in US / 中国药学杂志
Chinese Pharmaceutical Journal
;
(24): 66-71, 2019.
Artigo
em Chinês
| WPRIM
| ID: wpr-858113
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.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Idioma:
Chinês
Revista:
Chinese Pharmaceutical Journal
Ano de publicação:
2019
Tipo de documento:
Artigo
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