UNITED STATES
Landmark Legislation
FDA Modernization Act 2.0
December 2022. Removes animal testing mandate. Enables NAMs for IND submissions.
Read More →2024 Expansion
FDA Modernization Act 3.0
March 2024. Requires FDA NAMs training. Expands alternative method acceptance.
Read More →NIH Program
NCATS Tissue Chip
$200M+ NIH investment. Multi-phase program advancing MPS validation.
Read More →Qualification
FDA ISTAND Program
Innovative Science and Technology Approaches for New Drugs qualification pathway.
Read More →Chemical Safety
EPA NAMs Strategy
New Approach Methodologies for chemical safety assessment without animals.
Read More →Innovation
ARPA-H Programs
Advanced Research Projects Agency for Health. PROTEUS and biotech initiatives.
Read More →INTERNATIONAL
Europe
EMA 3Rs Framework
European Medicines Agency. Replace, Reduce, Refine animal testing.
Read More →Global Standards
OECD Test Guidelines
International test guideline program. TG 497, TG 498 for in vitro methods.
Read More →Harmonization
ICH Guidelines
International Council for Harmonisation. S9, M3(R2) for alternative methods.
Read More →