FDA Animal Rule: Overview & Impact On Drug Development

The Animal Rule, established by the FDA, applies to drugs and biological products for serious conditions caused by exposure to toxic agents when human trials are not possible. It requires efficacy demonstration in animal models and safety evaluation in humans. Products meeting specific criteria can be approved under this rule.

The Animal Rule has significant impacts on drug development, including efficiency through expedited review programs and regulatory considerations. It sets expectations for animal studies, including data integrity and compliance programs. Sponsors must navigate the Animal Rule by understanding its requirements, developing a comprehensive plan, ensuring data integrity, and following FDA guidelines.

ProPharma offers expertise in understanding the Animal Rule and its requirements. They provide services to support product development, study design, and regulatory strategy. See how their experts can help with FDA communications, study design, and data integrity to ensure compliance with the Animal Rule by accessing the full article below.