The FDA has released a draft guidance outlining how drug developers can validate new approach methodologies (NAMs) as alternatives to animal testing in preclinical drug development. The guidance, ...
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 ...
From drift to decision-making, why must European Union testing and regulatory frameworks evolve alongside application technology?