General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance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- General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance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
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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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- Jun 8, 2026Comment from Gautam DravidSupportIndividual📎 Attachment
Gautam Dravid, a PhD-level professional, provides technical feedback on the draft guidance for New Approach Methodologies (NAMs) in drug development. He suggests specific clarifications regarding context-of-use examples, donor sourcing, cellular maturity, and reagent lot variability to improve the reliability and regulatory utility of NAM-derived data.
Read comment → - May 18, 2026Comment from International Society for Stem Cell ResearchSupportAdvocacy📎 Attachment
The ISSCR Consortium on Advanced Stem Cell-Based Models in Drug Discovery and Development supports the draft guidance, commending its clear framework for integrating New Approach Methodologies (NAMs) into drug development. They provide specific recommendations to ensure the guidance remains flexible, explicitly recognizes computational and AI-integrated models, and accounts for the unique characterization needs of stem cell-derived models.
Read comment → - May 18, 2026Comment from Society of Quality AssuranceSupportAdvocacy📎 Attachment
The Society of Quality Assurance (SQA) supports the draft guidance but proposes several specific additions and clarifications to improve regulatory clarity. Their recommendations focus on enhancing validation requirements, improving transparency regarding AI/ML tools, and providing more detailed expectations for submission structures and data quality.
Read comment → - May 18, 2026Comment from American Gastroenterological AssociationSupportAdvocacy📎 Attachment
The American Gastroenterological Association (AGA) supports the draft guidance on New Approach Methodologies (NAMs) and recommends specific technical refinements to improve the reproducibility and reliability of organoid-based research.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.
Read comment → - Mar 19, 2026Comment from AnonymousSupportIndividual
The commenter suggests that the draft guidance should require more specific details regarding cell culture medium composition, serum batch numbers, and solvent control justifications. They also advocate for including studies from both male and female donors to ensure accurate results unless a drug is specifically for one sex.
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