Comment from Lonza
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Summary: Lonza, a pharmaceutical services company, submitted comments in support of the FDA's draft guidance on New Approach Methodologies (NAMs) in drug development. They state that the guidance will be helpful to drug developers in validating these new methodologies.
Lonza’s comments on the FDA’s Draft Guidance for Industry (Docket FDA-2025-D-6131) General Considerations for the Use of New Approach Methodologies in Drug Development are provided in the attached document.