A Guide to the FDA Announcement to Phase Out Animal Testing for Drugs

FDA’s Roadmap to Replace Animal Testing

How Certara’s Non-Animal Navigator™ is Shaping the Future of Drug Development

The FDA Modernization Act 2.0 and the FDA Roadmap to Reducing Animal Testing mark a turning point in preclinical drug development. For the first time, animal studies are no longer required before clinical trials.

By adopting advanced, human-relevant alternatives, drug developers can improve translational accuracy while meeting these regulatory and ethical standards.

Why the traditional animal testing paradigm for investigational drugs must change

Over 90% of drugs that pass animal studies fail in human trials

Traditional animal models often fall short in predicting human safety and efficacy. Human-relevant methods like biosimulation, microphysiological systems, and advanced in vitro assays (New Approach Methodologies; NAMs) can provide more reliable insights into drug safety and efficacy.

Phasing out your animal studies to comply with these regulations

Certara’s Non-Animal Navigator is a platform supporting transition to non-animal testing models. Our framework combines biosimulation tools and our experts’ services to build scientifically robust, regulator-ready evidence packages.

Download the Guide

A Guide to the FDA Announcement to Phase Out Animal Testing for Drugs explains what this shift means for pharmaceutical development and how to prepare your organization.

By reading this it, you’ll learn:

The global regulatory landscape for non-animal studies
Practical steps to build confidence with regulators
How Certara provides guidance tools for integrating NAMs into pre-clinical pipelines

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About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.