Federal Register Notice: FDA is making available a draft guidance, Animal Models — Essential Elements to Address Efficacy Under the Animal Rule. It identifies and discusses the critical characteristics of an animal model (used when human efficacy studies are not ethical or feasible) that should be addressed when developing products for approval under the Animal Rule. It is intended to help sponsors determine whether the model meets the requirements of the Animal Rule. To download this guidance, click here. To view this notice, click here.