Human Cell Tests and Computer Models Gain Formal Place in FDA Rules for Drug Safety Before First Trials

Human Cell Tests and Computer Models Gain Formal Place in FDA Rules for Drug Safety Before First Trials

FDA rewrote drug safety rules so that human cell tests and computer models can support first human trials. What it means for trial volunteers and patients.

FDA rewrites drug safety rules to allow human-cell testing over animal experiments

The FDA has issued a new rule letting drug makers use human-cell tests, organ chips and computer models instead of animal studies before human trials. The change replaces decades-old language that treated animal testing as the only accepted safety standard. Companies can still use animal studies when appropriate, and safety reporting requirements remain unchanged. The rule follows a broader Trump administration push, with NIH also funding $88…

FDA Updates Regulations to Advance Alternatives to Animal Testing

FDA Updates Regulations to Expand Use of Innovative Alternatives to Animal Testing New rule clarifies that validated non-animal methods can be used in drug and biologics development while maintaining existing safety standards The U.S. Food and Drug Administration (FDA) has issued a direct final rule updating its regulations to clarify that non-animal methods can be […]

FDA updates rules to advance non-animal, innovative testing in human drug development

Bigstock The U.S. Food and Drug Administration (FDA) has issued a direct final rule clarifying that non-animal methods may be used, when appropriate, to evaluate the safety of drugs and biological products intended for human use before clinical trials. The rule reflects advances in New Approach Methodologies (NAMs), including human cell-based systems, organ-on-chip technologies, computer models and other tools designed to better reflect human bi…