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By completing this path, you will be able to:

Navigate FDA Modernization Act 2.0 and 3.0 requirements for NAMs submissions
Develop robust Context of Use (COU) statements for regulatory acceptance
Apply for and secure FDA ISTAND qualification for novel NAMs platforms
Understand EMA, OECD, and ICH frameworks for international harmonization
Design validation studies that meet regulatory standards
Build comprehensive NAMs dossiers for drug approval submissions
Leverage successful case studies to strengthen your submission strategy

Module 1: FDA Modernization Act 2.0 & 3.0

Understand the historic 2022 legislation that ended the 84-year animal testing mandate. Learn what changed, what it means for drug development, and how to leverage FDA 3.0 in your submissions.

Complete FDA Guide FDA 3.0 Details

Module 2: FDA ISTAND Program Deep Dive

Master the Innovative Science and Technology Approaches for New Drugs program. Learn the qualification process, submission requirements, and how to position your NAMs technology for ISTAND acceptance.

ISTAND Overview NCATS Tissue Chip Program

Module 3: Context of Use (COU) Development

Develop clear, defensible Context of Use statements that define when, where, and how your NAMs technology can replace animal models. Learn FDA's COU framework and qualification pathway.

COU Framework Supporting Evidence

Module 4: EMA and European NAMs Framework

Navigate the European Medicines Agency's approach to NAMs acceptance. Understand the 3Rs principles (Replace, Reduce, Refine), EMA guidance documents, and how to align submissions across FDA and EMA.

EMA 3Rs Strategy ICH Guidelines

Module 5: OECD Test Guidelines & International Standards

Explore the Organisation for Economic Co-operation and Development (OECD) test guidelines for NAMs. Learn how international standards facilitate global regulatory acceptance and streamline multi-country submissions.

OECD Guidelines ICH Harmonization

Module 6: Validation & Qualification Strategies

Design robust validation studies for NAMs platforms. Learn the difference between analytical validation, biological qualification, and regulatory acceptance. Understand statistical requirements and study design principles.

Validation Methods Research Standards

Module 7: EPA NAMs Roadmap & Environmental Testing

Discover the EPA's commitment to phasing out mammalian testing by 2035. Learn how NAMs are being integrated into environmental chemical assessments, pesticide registration, and toxicity testing programs.

EPA NAMs Strategy Environmental Applications

Module 8: Building Your NAMs Submission Dossier

Construct a comprehensive regulatory submission package. Learn documentation requirements, data presentation strategies, and how to address reviewer concerns proactively. Includes IND, NDA, and BLA considerations.

Submission Guidance Documentation Templates

Module 9: Case Studies - Successful NAMs Submissions

Analyze real-world examples of NAMs successfully replacing animal studies in regulatory submissions. Learn from Emulate's Liver-Chip ISTAND qualification, organoid approvals, and computational model acceptances.

Company Case Studies Clinical Evidence

Module 10: Funding & ARPA-H Opportunities

Explore federal funding mechanisms for NAMs development. Understand ARPA-H initiatives, NIH grants, SBIR/STTR programs, and how to position your technology for government support while advancing regulatory acceptance.

ARPA-H Programs NCATS Funding

What's Next?

Ready to advance your NAMs expertise? Explore our other learning paths or dive into specific technology guides.

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⚖️ Regulatory Affairs Path