---
type: entity
entity_type: organization
name: FDA Modernization Act 3.0
domain: health
status: active
---

# FDA Modernization Act 3.0

## Overview

Legislative act passed by unanimous consent in the U.S. Senate in December 2025, building on FDA Modernization Act 1.0 (2022) which removed mandatory animal testing for IND applications. Directs FDA to create formal pathway for qualification, review, and routine acceptance of non-animal testing methods (NAMs) in drug development.

## Key Provisions

- Establishes formal regulatory pathway for New Approach Methodologies (NAMs)
- Puts FDA "on a clock" to translate legal authority into day-to-day regulatory practice
- Closes remaining gaps in NAMs adoption from 2022 legislation
- Applies to AI-based computational toxicity models, organoids, and organ-on-chip technologies

## Timeline

- **2022** — FDA Modernization Act 1.0 removed mandatory animal testing requirement for IND applications
- **2025-04** — FDA announced plan to phase out animal testing requirements for monoclonal antibodies and other drugs
- **2025-12** — FDA Modernization Act 3.0 passed Senate by unanimous consent
- **2025-12** — FDA issued draft guidance for reducing nonhuman primates in mAb toxicity studies

## Implementation Status

As of December 2025, House passage status unclear. Senate passage was unanimous, indicating broad bipartisan support. FDA implementation timeline expected 2025-2028 for formalized guidance.

## Related Developments

FDA April 2025 announcement encouraged NAMs data in IND applications and promised streamlined review pathway for strong non-animal safety data. December 2025 draft guidance provides specific protocols for reducing nonhuman primate use in monoclonal antibody toxicity studies after initial 3-month testing period.