The FDA has released a draft guidance outlining how drug developers can validate new approach methodologies (NAMs) as ...
The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM ...
The U.S. Food and Drug Administration issued a draft guidance on Wednesday to help drug developers validate alternative methods that can be used in place of animal studies during early stages of drug ...
Early 2026 has brought a series of consequential regulatory moves from the FDA, each reflecting a common thread: the agency ...
Health authorities in the U.S. are continuing their move away from animal testing in drug development, with the FDA signaling ...
Federal regulators in the United States are pushing harder than ever to reduce and eventually replace animal testing in drug ...
FDA’s NAM framework emphasizes context of use, human biological relevance, technical characterization, and fit-for-purpose ...
This is the latest in a series of steps the agency has taken over the past two years to reduce reliance on animal testing. In ...