FDA Draft Guidance Signals Flexibility on Reducing Animal Testing, Law360

Partner Jacqueline R. Berman was quoted by Law360 Healthcare Authority in an article about the US Food and Drug Administration's draft guidance on the use of nonanimal methods, known as new approach methodologies (NAMs), in preclinical drug development.

The article examines how the draft guidance signals the FDA's willingness to consider alternatives to animal testing while leaving important questions about implementation to be resolved through sponsor engagement and future regulatory experience. Jacqueline described the guidance as a "mixed bag," noting that while it provides limited specificity, it demonstrates flexibility by allowing regulators to consider nonanimal methods even without formal validation. "The big question is what NAMs FDA will accept and what they will substitute for," Jacqueline said. She added, "And I think that we'll only really see as industry begins to use these, begins to talk with FDA about these, and products that have relied on these work their way through the pipeline." Jacqueline also emphasized the importance of early engagement with the agency, noting, "It's really important for companies who are thinking about using these to talk to FDA — because it will initially likely be a case-by-case decision."

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