Before revision: Summary The FDA can rely on evidence from animal studies to provide substantial evidence of product effectiveness 1 : There is a reasonably well-understood mechanism for the toxicity of the agent and its amelioration or prevention by the product; 2: The effect is demonstrated in either: 2.1: More than one animal species expected to react with a response predictive for humans; or 2.2: One well-characterized animal species model (adequately evaluated for its responsiveness in humans) for predicting the response in humans.
After revision: Summary The FDA can rely on evidence from animal studies to provide substantial evidence of product effectiveness if : There is a reasonably well-understood mechanism for the toxicity of the agent and its amelioration or prevention by the product; The effect is demonstrated in either: More than one animal species expected to react with a response predictive for humans; or One well-characterized animal species model (adequately evaluated for its responsiveness in humans) for predicting the response in humans.