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. • The animal
study endpoint is clearly related to the desired benefit in humans; and • Data or information on the
pharmacokinetics and
pharmacodynamics of the product or other relevant data or information in animals or humans is sufficiently well understood to allow selection of an
effective dose in humans, and it is, therefore, reasonable to expect the effectiveness of the product in animals to be a reliable indicator of its effectiveness in humans. FDA published a
Guidance for Industry on the Animal Rule in October 2015. ==References==