New Approach Methodologies Archives - Quality Solutions Now (QSN)

FDA’s Draft Guidance on Alternatives to Animal Testing: What Quality Teams Should Do Now
On March 18, 2026, FDA announced a new draft guidance focused on validating New Approach Methodologies (NAMs). These methods are intended to support drug development decisions without relying on traditional animal testing as the default. [...]
FDA to Phase Out Animal Testing Requirements, Promising Accelerated Cures and Smarter Drug Development
In April 2025, the U.S. Food and Drug Administration (FDA) unveiled their roadmap designed to reduce, refine, and potentially replace animal testing, beginning with monoclonal antibody therapies and expanding to other drug modalities. This marks [...]