General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance

The United States Pharmacopeia (USP) supports the draft guidance on using new approach methodologies (NAMs) in drug development, noting its alignment with human-centric, nonanimal testing and global scientific efforts. They advocate for a weight-of-evidence framework for evaluating novel excipients and emphasize the importance of integrating NAMs data to reduce animal testing.

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Consortium for Innovation and Quality in Pharmaceutical Development (IQ) submitted comments supporting the draft guidance on New Approach Methodologies (NAMs) in drug development.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 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.

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Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center, expresses strong support for the draft guidance on New Approach Methodologies (NAMs) in drug development.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.

Bexorg, a translational research company, supports the draft guidance for using New Approach Methodologies (NAMs) in drug development, particularly for CNS programs. They argue that the guidance's focus on "fit-for-purpose" validation and a weight-of-evidence framework is essential for incorporating human-relevant data to reduce high clinical failure rates.

Genentech, a biotechnology company, supports the draft guidance on New Approach Methodologies (NAMs) and commends the FDA's flexibility in its approach.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.

The Institute for In Vitro Sciences, a non-profit research and testing laboratory, expresses strong support for the draft guidance, noting it provides a necessary framework for the validation and use of non-animal methods (NAMs) in drug development. They suggest specific improvements to the guidance, including clearer validation expectations, more detail on human biological relevance, and the inclusion of a recommended submission structure for sponsors.

The Biotechnology Innovation Organization (BIO) supports the FDA's draft guidance on New Approach Methodologies (NAMs) as a step toward modernizing nonclinical safety assessments and reducing animal testing. They request additional clarity on regulatory decision-making, validation requirements, and specific implementation details to provide sponsors with greater confidence and consistency.