FDA begins phasing out animal testing with AI and lab models

USA – The U.S. Food and Drug Administration (FDA) is taking big steps to reduce the use of animals in drug testing.

Instead, the agency plans to use newer, human-based methods—like artificial intelligence (AI), lab-grown tissue models, and organ-on-a-chip systems.

This shift is supported by the FDA Modernization Act of 2022. For the first time, this law allowed drug developers to use non-animal methods to test the safety and effectiveness of new medicines before human trials.

The new plan will first focus on testing monoclonal antibodies (mAbs). These are drugs used to treat serious diseases like cancer, immune disorders, and infections. The FDA says the new approach could help create safer drugs more quickly, and at a lower cost.

The agency is now encouraging drug makers to submit data from new methods, such as computer simulations, lab-made mini-organs, and other in-vitro (lab-based) systems.

In some cases, the FDA will also accept safety data from other countries with similar health standards—helping to avoid repeating the same tests in animals.

A pilot program will launch soon, allowing a few drug companies to try this new process. These companies will mostly use non-animal methods, with the FDA watching closely. For now, this applies only to developers of monoclonal antibody drugs.

FDA Commissioner Martin Makay called the plan “a major change in how we test drugs.” He added that this change could lead to faster drug approvals and better protection for animals.

Still, experts say the change will take time. Investment firm William Blair said the update is more of a goal than a strict rule. They believe many companies will still choose to do some animal testing—especially to meet international rules.

The news has already affected companies. Charles River Laboratories, which makes money from animal testing (including tests on monkeys), saw its stock price drop by 28%.

On the other hand, companies that focus on AI and computer-based testing—like Certara and Simulations Plus—may benefit in the long run.

Recent research shows this is possible. Scientists in Germany created a tiny lab model of pancreatic cancer and tested a real cancer drug on it—getting promising results.

Big pharma companies like AstraZeneca are also using AI to understand how cancer cells react to medicine, helping them design better treatments.