The U.S. Food and Drug Administration has issued a draft guidance intended to help drug developers validate new approach methodologies to be used instead of animal testing in drug development, and to bring safe, effective drugs to market sooner based on human-centric data.
This marks another major milestone in the implementation of the FDA's roadmap to reducing animal testing, and moving away from using animal testing as the default method for gaining drug safety information. The draft guidance describes the Center for Drug Evaluation and Research's general recommendations to consider for validating NAMs when nonclinical NAMs data are provided in support of a drug application or regarding an order issued under section 505G of the FD&C Act for an OTC monograph.
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