Resources for the Animal Model Qualification Program

Programs and Initiatives

• FDA Drug Development Tools Qualification Programs – Information about drug development tools and the qualification process
• FDA Medical Countermeasures Initiative – Information about the FDA initiative to coordinate medical countermeasure development, preparedness, and response

Laws, Regulations, and Policies

• Animal Rule (21 CFR 314.600-650 for drugs, 21 CFR 601.90-95 for biological products)
• 21st Century Cures Act (section 3011)
• USDA Animal Welfare Information Center – Animal Welfare Act and Regulations
• NIH Office of Laboratory Animal Welfare – Policies and Laws

FDA Guidances

• Qualification Process for Drug Development Tools (final, November 2020)
• Product Development Under the Animal Rule (final, October 2015)

Animal Rule Approvals and Licensures 

List of CDER-and CBER-regulated products approved and licensed under the Animal Rule

Inspection Compliance Program

Compliance Program for the Inspection of Nonclinical Laboratories Conducting Animal Rule-Specific Studies (Program 7348.007)

Data Standards

• Standard for Exchange of Nonclinical Data Implementation Guide – Animal Rule (SENDIG-AR)
• FDA Study Data Standards Resources

Questions can be sent to the AMQP email inbox at CDERAnimalModelQualification@fda.hhs.gov.