FDA to phase out animal testing requirements

Published: Apr. 11, 2025 at 10:59 AM EDT

(CNN) - The Food and Drug Administration said it will phase out a requirement that certain drugs and monoclonal antibodies be tested on animals.

In a statement, the FDA said it’s taking this step because there are testing methods that are more effective and “human-relevant.”

The agency said one possible replacement for animal testing includes AI-based computer simulations or even lab-grown human “organoids.”

A drug can get FDA approval only after researchers show it is safe and effective.

Until now, that proof has had to be shown through lab testing, often in animals, before therapies are tested in humans.

Animals have been considered good stand-ins at the stage of clinical trials where it would be too dangerous to test on humans.

In 2022, Congress passed a bill, which later became law, that allowed sponsors of new drugs to use animal testing alternatives.

The FDA commissioner said this new move will get new treatments into the hands of patients more quickly while lowering drug prices.