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  • 标题:Sometimes the Silence Can Be like the Thunder: Access to Pharmaceutical Data at the FDA
  • 本地全文:下载
  • 作者:Lurie, Peter ; Zieve, Allison
  • 期刊名称:Law and Contemporary Problems
  • 印刷版ISSN:0023-9186
  • 出版年度:2006
  • 卷号:69
  • 期号:3
  • 页码:85-98
  • 出版社:Duke Law
  • 摘要:Those committed to the free exchange of scientific information have long complained about various restrictions on access to the FDA's pharmaceutical data and the resultant restrictions on open discourse. A review of open-government procedures and litigation at the FDA demonstrates that the need for transparency at the agency extend well beyond the reach of any clinical trial registry.
  • 关键词:FDA approval; Public access; Pharmaceuticals; Accountability; Disclosure; Freedom of information; Drug approval; Clinical trials
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