General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance

The United States Pharmacopeia (USP) supports the draft guidance on using new approach methodologies (NAMs) in drug development, noting its alignment with human-centric, nonanimal testing and global scientific efforts.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.

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.

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.

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Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center, expresses strong support for the draft guidance on New Approach Methodologies (NAMs) in drug development.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

The Society of Quality Assurance (SQA) supports the draft guidance but proposes several specific additions and clarifications to improve regulatory clarity.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.

The 3Rs Collaborative, a non-profit organization, supports the draft guidance on New Approach Methodologies (NAMs) in drug development, commending the FDA's realistic and scientifically grounded approach. They recommend expanding the guidance to include specific in silico model validation frameworks and suggest that the FDA engage in more public workshops and scientific society meetings.

The commenter supports the draft guidance but argues that it is disproportionately weighted toward in vitro systems. They request that the document be balanced to include more specific mentions and technical details regarding in silico approaches and secondary pharmacology profiling.

The Arab Union of Pharmaceutical Manufacturers (AUPAM), through its Arab Expert's Office, supports the draft guidance on New Approach Methodologies (NAMs) in drug development. They provide twelve constructive, low-burden edits aimed at clarifying definitions, expanding worked examples, and aligning the guidance with existing FDA and international frameworks.

The International Society for CNS Clinical Trials and Methodology (ISCTM) supports the draft guidance on New Approach Methodologies (NAMs) in drug development. They suggest specific improvements, including clarifying international harmonization, establishing a public registry for accepted NAMs, and refining technical language to better incorporate real-world evidence and human-relevant data.

ESQlabs, a contract research organization, supports the FDA's draft guidance on New Approach Methodologies (NAMs) as a positive step toward integrating human-relevant methods in drug development. They provide 16 specific recommendations to improve the guidance's operationality, including more granular taxonomy, clearer rules for handling conflicting data, and the inclusion of anonymized case studies.