General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance

Amgen, a global biotechnology and pharmaceutical company, supports the draft guidance on New Approach Methodologies (NAMs) for drug development. They request specific improvements to clarify regulatory pathways, provide practical implementation examples, expand the scope to include complex modalities and in silico data, and improve the guidance on human biological relevance and validation.

The Critical Path Institute (C-Path) supports the draft guidance on New Approach Methodologies (NAMs) in drug development, commending the FDA's efforts to modernize regulatory science. They suggest specific enhancements to clarify "fit-for-purpose" principles, recognize data-sharing infrastructure, and better address multi-platform evidence integration and disease heterogeneity.

The Arab Expert's Office at the Arab Union of Pharmaceutical Manufacturers (AUPAM) supports the draft guidance on New Approach Methodologies (NAMs) in drug development, praising its structural framework and scientific grounding. They propose twelve specific technical revisions to improve clarity on validation standards, data integrity, AI/ML integration, and global reliance pathways to ensure the guidance is internationally interoperable and practical for manufacturers.

Battelle Memorial Institute, a contract research organization (CRO), supports the FDA's draft guidance on New Approach Methodologies (NAMs) in drug development. They request additional practical examples, clearer operational details on the "fit-for-purpose" framework, and more explicit guidance on how NAM data will be integrated into regulatory decision-making.

Stefano Gaburro, an independent scientific consultant and lead of a working group, supports the intent of the draft guidance to integrate nonclinical testing alternatives into drug development. He argues for specific revisions to improve scientific precision, including replacing the broad term "NAM" with specific categories, adding dedicated validation for in silico methods, and explicitly integrating the 3Rs framework.

The commenter, identifying as "Freeman," submits a comprehensive strategic framework to optimize the HHS and FDA's "Fewer Animals, Better Data, Faster Cures" initiative. They propose 24 specific innovations—including data standards, reviewer training, and blockchain infrastructure—to accelerate the adoption of New Approach Methodologies (NAMs) while ensuring legal durability and scientific rigor.