The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM ...
The FDA has released a draft guidance outlining how drug developers can validate new approach methodologies (NAMs) as ...
The U.S. Food and Drug Administration issued a draft guidance on Wednesday to help drug developers validate alternative methods that can be used in place of animal studies during early stages of drug ...
FDA’s NAM framework emphasizes context of use, human biological relevance, technical characterization, and fit-for-purpose ...
Health authorities in the U.S. are continuing their move away from animal testing in drug development, with the FDA signaling ...
Non-animal testing methods could save drugmakers time and money, officials say ...
Early 2026 has brought a series of consequential regulatory moves from the FDA, each reflecting a common thread: the agency ...
IRVINE, CA, UNITED STATES, March 17, 2026 /EINPresswire.com/ — Qalitex Laboratories, an ISO 17025-accredited third-party ...