The FDA’s plan to phase out animal testing is a transformative step that paves the way for innovative, human-relevant preclinical approaches that are more predictive, efficient, and ethical. There is a long history at the FDA of using validated new approach methodologies (NAMs), including in silico tools and computational modeling as a framework for regulatory decision-making to support this transition effectively.
As a global leader in Model-Informed Drug Development (MIDD) strategies, Certara is ready to support the industry with a comprehensive offering of advanced modeling tools and development expertise that directly align with the FDA’s vision for the future of drug development.