Emergency Preparedness and Response

Animal Rule Information

Gloved hand working with lab equipment at FDA headquarters at White Oak, MDBefore a medical product can be approved by FDA, the sponsor must prove efficacy—that the product works. In some cases, such as developing medical countermeasures for potential bioterror threats, human challenge studies (exposing people to the threat agent) would not be ethical or feasible.

In these cases, FDA may grant approval based on well-controlled animal studies, when the results of those studies establish that the drug or biologic product is reasonably likely to produce clinical benefit in humans. The product sponsor must still demonstrate the product’s safety in humans.

Final Guidance for Industry: Product Development Under the Animal Rule (PDF, 574 KB)
August 2016: FDA is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. As part of proposed changes to this rule, FDA seeks comment on the impact of expanding part 58 to include covered Animal Rule studies, and what other changes to the regulations, beyond amending the scope and definitions, are needed to address issues unique to covered Animal Rule studies. Comment by November 22, 2016.

Page Last Updated: 08/24/2016
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