Comment from American Gastroenterological Association
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Summary: The American Gastroenterological Association (AGA) supports the draft guidance on New Approach Methodologies (NAMs) and recommends specific technical refinements to improve the reproducibility and reliability of organoid-based research. They advocate for more rigorous disclosure of growth factors, statistical units (biological vs. technical replicates), donor clinical context, and specific organoid configurations to ensure accurate regulatory review.
On behalf of the American Gastroenterological Association (AGA), we appreciate the opportunity to submit comments in response to the Food and Drug Administration’s (FDA) draft guidance, “General Considerations for the Use of New Approach Methodologies in Drug Development. Please see the attached file.