Comment from Cruelty Free International
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Summary: Cruelty Free International supports the draft guidance, praising its emphasis on human-relevant non-animal methods (NAMs) and regulatory flexibility. They suggest improvements regarding clearer terminology definitions, more illustrative examples of in silico approaches, and further efforts toward international harmonization and specific context-of-use guidance.
Please find attached comments from Cruelty Free International on the FDA draft guidance, “General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry.”
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