Overview
- HHS published on Monday a public account of more than 20 department actions to expand New Approach Methodologies, or NAMs, which use human organoids, tissue models, AI and computer modeling instead of animal tests.
- The Food and Drug Administration issued a finalized rule that clarifies nonanimal data may be used for regulatory decisions and replaces older language that could imply animal tests were the only acceptable evidence.
- The National Institutes of Health pledged $88 million for NAMs infrastructure and announced a new NIH Clinical Center laboratory to develop standardized human organoid models, robotics and advanced data tools.
- Agencies reported concrete animal-welfare steps: NIH closed its last intramural beagle lab and allows grants to fund retirements or rehoming, while CDC is reducing its lab animal colony, adding extra review for animal studies, and placing healthy primates in sanctuaries.
- ARPA-H is funding AI and computational modeling through CATALYST programs to improve drug-safety predictions, and HHS estimates the changes could spare hundreds of primates and more than one million horseshoe crabs as validation and regulatory integration continue.