FDA Releases Draft Guidance on Alternatives to Animal Testing in Drug Development

WHY IT MATTERS

Patients with rare diseases could gain access to new treatments faster if drug developers can use these human-centered testing methods instead of spending years on animal studies.

The FDA released new guidelines to help drug companies test medicines using human-based methods instead of animal testing. These new testing approaches could make it faster and safer to develop drugs by using data that better reflects how humans respond. This is part of the FDA's effort to bring effective treatments to patients more quickly.

The U.S. Food and Drug Administration today issued draft guidance intended to help drug developers validate new approach methodologies (NAMs) to be used instead of animal testing in drug development, and to bring safe, effective drugs to market sooner based on human-centric data.