Drug makers and animal testing groups urge FDA to keep flexible guidance on animal studies for cancer drugs

A coalition of drug developers, regulators and laboratory animal-testing organizations has asked the U.S. Food and Drug Administration to keep its guidance on cancer-drug safety studies flexible.

The groups argue that while animal testing remains valuable, emerging alternatives such as in-vitro models, computational simulations and real-world evidence can sometimes provide sufficient safety data.

They want the FDA to allow case-by-case decisions about when animal data are required, which they say could speed development and reduce unnecessary animal use.