General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance

Gautam Dravid, a PhD-level professional, provides technical feedback on the draft guidance for New Approach Methodologies (NAMs) in drug development.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.

Kelsey Kern, writing as a concerned citizen, supports the transition to non-animal methodologies (NAMs) in drug development and basic research. The commenter argues that animal testing is not scientifically validated and advocates for a 24-month roadmap to replace animal models with technologies like organoids, AI, and organ-on-chips.

VivoSim Labs, Inc., a company developing 3D human tissue models for drug safety, supports the draft guidance and commends the FDA's validation framework. They recommend expanding the guidance to include non-human NAM models, clarifying which contexts of use will be validated, and urging the FDA to require NAM liver toxicity screening for IND applications due to its high predictive accuracy.

Case Lorance, CEO of NEXI Biotech, supports the draft guidance but argues it must be expanded to include efficacy-oriented New Approach Methodologies (NAMs) rather than just safety. The commenter proposes a structured industry-sponsored validation pathway, a dedicated efficacy track within ISTAND, and a Priority Review Voucher-equivalent to incentivize biopharma companies to invest in and qualify these technologies.

The Alliance for Cruelty Free Science submits a technical feasibility briefing advocating for a rapid, two-phase transition from animal-based research to human-relevant New Approach Methodologies (NAMs). They argue that the transition is technically feasible within 24 months due to mature technologies like AI, organoids, and VR, and provide a comprehensive framework for infrastructure conversion and workforce retraining.

Moffitt Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center, expresses strong support for the draft guidance on New Approach Methodologies (NAMs) in drug development. They argue that the guidance provides a necessary, scientifically grounded validation framework that will accelerate the translation of human-relevant science into safe and effective therapies.

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.

The Physicians Committee for Responsible Medicine (PCRM) supports the FDA's draft guidance on New Approach Methodologies (NAMs) in drug development. They advocate for revisions that emphasize flexible, fit-for-purpose validation strategies, prioritize human biological relevance, and move away from a heavy reliance on historical animal testing.

The International Foundation for Ethical Research (IFER), a nonprofit funding academic research, supports the draft guidance but urges the FDA to prioritize human biological relevance over animal data concordance as the primary evidentiary standard. They also recommend establishing tiered validation requirements based on the specific context of use and expanding early engagement opportunities to include academic researchers.

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.