General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance
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- Title
- General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance
- Posted
- Mar 19, 2026
- Comment period
- Mar 19, 2026 – May 19, 2026
- Topics
Overview
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Stance breakdown
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| Organization | Animal model necessity | Animal testing alternatives | Cell culture and donor requirements | In silico modeling inclusion | Nam data infrastructure standards |
|---|
28 organization-typed comments could not be identified.
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- May 18, 2026Comment from Genentech, Inc.SupportBusiness📎 Attachment
Genentech, a biotechnology company, supports the draft guidance on New Approach Methodologies (NAMs) and commends the FDA's flexibility in its approach. They provide specific recommendations to clarify definitions, refine terminology regarding "validation" versus "proof of scientific validity," and ensure the guidance remains practical for diverse drug modalities.
Read comment → - Apr 1, 2026Comment from Biomarker Solutions LLCSupportIndividual
The commenter suggests updating the BEST (Biomarkers, EndpointS, and other Tools) Resource to include a specific definition for "NAM-based biomarker." They provide draft verbiage to ensure terminology consistency with the proposed guidance.
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