General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance

Michael McCue, a concerned citizen, supports the transition to non-animal methods (NAMs) in drug development and research. He urges the FDA to acknowledge the lack of scientific validation for animal testing and to adopt a 24-month roadmap for replacing animal models with modern technologies like organoids and AI.

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.

The commenter, identifying as a consumer and taxpayer, supports the transition to non-animal testing methodologies. They urge the FDA to establish a clear timeline to phase out animal testing by the end of fiscal year 2027.

Michael McCue, a concerned citizen, supports the transition to non-animal methods (NAMs) in drug development and research. He urges the FDA to acknowledge the lack of scientific validation for animal testing and to adopt a 24-month roadmap for replacing animal models with modern technologies like organoids and AI.

VivoSim Labs, Inc., a company developing 3D human tissue models for drug safety, supports the draft guidance and commends the FDA's validation framework.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.

The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) submitted comments supporting the draft guidance on New Approach Methodologies (NAMs) in drug development. They provide specific technical recommendations to clarify definitions, emphasize the "fit-for-purpose" principle over mandatory validation, and request more detail on in silico methods and human biological relevance.

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.

The Consumer Healthcare Products Association (CHPA), a trade association representing manufacturers of over-the-counter medicines and dietary supplements, supports the FDA's endorsement of New Approach Methodologies (NAMs). They advocate for clearer guidance on integrating NAMs into regulatory frameworks, more transparent stakeholder engagement, and a focus on human relevance rather than strict performance comparisons against traditional animal tests.

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.

Vanda Pharmaceuticals Inc. argues that the Draft Guidance is insufficient because it fails to fully implement the agency's goal of replacing animal testing with human-centric methodologies. The company recommends several revisions, including removing requirements to benchmark new approach methodologies (NAMs) against animal studies and rescinding outdated international guidelines that mandate lengthy animal testing.