The U.S. Food and Drug Administration is actively steering drug developers away from traditional animal studies and toward human-biology-based testing methods for monoclonal antibody programs. The ...
The FDA has released a draft guidance outlining how drug developers can validate new approach methodologies (NAMs) as alternatives to animal testing in preclinical drug developmen ...
Non-animal testing methods could save drugmakers time and money, officials say ...
In April 2025, the FDA announced plans to shift biomedical research for monoclonal antibodies and other medications away from animal testing toward new approaches. One year later, much speculation ...
A2LA-accredited Irvine lab explains why accredited vs. self-declared compliance determines COA acceptance by Amazon, ...