US FDA Expects to Spur Options to Animal Testing by Inserting ‘Nonclinical’ in Regulatory Language, HBW Insight

HBW Insight quoted partner Rachel Raphael in an article about a US Food and Drug Administration (FDA) rule updating regulatory language to recognize non-animal approaches to nonclinical testing in drug and biological product development.

Rachel noted that the rule does not impose new requirements, eliminate animal testing, or automatically approve new approach methodologies, and that “FDA expressly states that there are circumstances where animal testing is important and necessary.”

While she does not expect immediate changes, Rachel said, “we should see effects on practices over time, with a more gradual and incremental shift away from animal testing toward alternative approaches.”

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