US regulation and policy

Status at a glance (October 2026)

Item	Body	Stage
FDA Modernization Act 2.0	Congress	Law since December 2022
FDA Modernization Act 3.0	Congress	Passed Senate (Dec 2025) and House (Jul 2026) as separate bills; final Senate vote pending
Roadmap to reduce animal testing	FDA	Published April 2025; Year One report April 2026
Monoclonal antibody nonclinical safety	FDA	Draft guidance, December 2025
General considerations for NAMs	FDA CDER	Draft guidance, March 2026
Oncology biologics and conjugates	FDA	Draft guidance, May 2026
ORIVA	NIH	Launched June 2026
Complement-ARIE	NIH	$150M+ awarded March 2026
2035 mammalian testing goal	EPA	Recommitted January 2026
CATALYST computational safety models	ARPA-H	Eight teams named December 2025

Congress

The 2022 law changed the statute, but FDA regulations still reference animal tests. FDA Modernization Act 3.0 would require FDA to issue an interim final rule within one year that replaces those references with nonclinical language. The Senate passed S.355 by unanimous consent on December 16, 2025. The House passed H.R. 2821 by voice vote on July 20, 2026. Because the bill numbers differ, the Senate must still pass the House version before it reaches the President. We found no record of that vote as of this update.

FDA

The April 2025 roadmap started with monoclonal antibodies and set a three to five year horizon for making animal studies the exception. The April 2026 Year One report says first-year goals were met: ISTAND became a permanent program, FDA launched a NAMs acceptability database, updated endotoxin testing guidance, and qualified its first AI drug development tool.

The March 2026 draft guidance gives sponsors a validation framework with four considerations: context of use, human biological relevance, technical characterization, and fit for purpose. Reactions split. Some see a clear structure. Others, including Vanda Pharmaceuticals, argue it adds barriers.

Qualification in practice

ISTAND runs in three steps: letter of intent, qualification plan, full qualification package. Emulate's Liver-Chip entered in September 2024 and filed its full package in September 2026. FDA metrics dated January 1, 2026 listed no fully qualified ISTAND tools. The first decision will set the template for the field.

NIH

NIH said in April 2025 it would prioritize human-based research. From July 2025 it stopped issuing animal-only funding opportunities. In March 2026 it made the first Complement-ARIE awards ($150M+): five technology development centers, a NAMs data hub, a validation and qualification network with FNIH, and a $7M challenge with FDA and EPA. ORIVA launched in June 2026 with one division for extramural investment and one that absorbs NICEATM.

ARPA-H

CATALYST funds AI and computational models of ADME-Tox and physiology meant to support regulatory filings: up to $125M over 4.5 years. ARPA-H named eight teams in December 2025, including Draper (with Revalia Bio), Deep Origin, Inductive Bio, the Jackson Laboratory and Cedars-Sinai.

EPA

TSCA has required EPA to promote alternatives since 2016. EPA set a 2035 goal to end mammalian testing in 2019, dropped it in 2021, and recommitted in January 2026. In June 2026 it updated its list of accepted NAMs for TSCA and FIFRA for the first time in five years. EPA policy has reversed before, so treat its timelines as political rather than fixed.