The FDA's regulatory role in the ICCVAM process

Area of Science:

• Toxicology
• Regulatory Science
• Animal Welfare

Background:

• The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) was established to validate toxicological test methods.
• ICCVAM aims to reduce, refine, or replace animal use in research and testing.
• Fifteen federal agencies participate in ICCVAM's cross-agency efforts.

Purpose of the Study:

• To outline the US Food and Drug Administration's (FDA) processes for responding to ICCVAM recommendations.
• To detail how the FDA evaluates and implements validated alternative toxicological methods.
• To ensure regulatory acceptance and adoption of new testing strategies.

Main Methods:

• ICCVAM identifies, standardizes, validates, and harmonizes alternative toxicological test methods.
• The FDA reviews ICCVAM recommendations for validity and technical acceptability.
• FDA centers independently assess method applicability to their regulated products.

Main Results:

• The FDA has established internal processes to respond to ICCVAM recommendations.
• Each FDA center determines the appropriateness of implementing ICCVAM-validated methods.
• Implementation ensures compliance with regulatory obligations for product safety.

Conclusions:

• The FDA's independent review ensures validated methods meet specific regulatory needs.
• The process supports the adoption of alternative methods to enhance product safety and human health protection.
• Notification and training processes facilitate the use of newly adopted methods.