WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has issued a draft guidance intended to help drug developers validate new approach methodologies to be used instead of animal testing in drug development, and to bring safe, effective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 The draft guidance describes the Center for Drug Evaluation and Research's general recommendations to consider for validating NAMs when nonclinical NAMs data are provided in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.
'This draft guidance advances our commitment to replace animal testing with human-relevant, scientifically rigorous methods' said Health Secretary Robert F. Kennedy Jr. 'Clear validation expectations will help modern tools earn regulatory confidence and speed safer, more effective therapies to patients.'
Under the FDA's regulations, drug sponsors must submit nonclinical pharmacology and toxicology data before investigational drugs can proceed to clinical trials. While many studies have traditionally been conducted in animals, CDER routinely reviews data from NAMs when the methodology demonstrates reliability and scientific validity.
Examples of NAMs include innovative testing approaches such as complex and two-dimensional in vitro (laboratory) studies; three-dimensional models such as organoids, spheroids and organs on chips; chemical reactivity studies; computer simulations or in-silico modeling; and studies using 'phylogenetically lower' animals such as zebrafish or C. elegans. There are now several examples of validated NAMs outperforming unvalidated animal models in predicting human responses to drugs. NAMs can identify toxicities, demonstrate how the investigational drug works, improve predictivity of nonclinical studies, and enhance the safety of future clinical trials.
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