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Foley says it published an analysis of FDA’s nonclinical testing terminology rule
Foley said it published an analysis of FDA’s September direct final rule on nonclinical testing terminology and its interaction with draft guidance on new approach methodologies. The firm said the rule replaces animal-focused terminology without imposing new testing requirements and is scheduled to take effect on February 4, 2027.
Key points
- Foley said comments are due December 7, 2026, and significant adverse comments could lead to withdrawal.Foley
- The firm said the definition includes computer modeling, organ chips, cell-based assays and animal studies.Foley
- Foley said FDA’s draft guidance assesses context of use, biological relevance, technical characterization and fitness for purpose.Foley
- The firm said a method’s inclusion in FDA’s use-case database does not constitute general approval.Foley