FDA 改写药物检测法规以“非临床”替代动物研究并公开征求意见至12月7日

FDA on animal testing

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FDA 近期改写药物检测法规，以更宽泛的“非临床”替代动物研究，公开征求意见截至12月7日。该规则为新方法留出空间，但未明确 FDA 将采信哪些数据，也未说明不同模型如何在单一申报资料中协同使用。

正文

The FDA has recently rewritten its drug testing regulations to replace animal studies with the broader term nonclinical, and public comments are open through Dec. 7th. One open question for sponsors is what will actually fill that wider category? The rule makes room for new methods but says little about which data FDA will trust or how different models should work together in a single package.

See: Federal Register

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)