FDA on animal testing

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/)