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April 29 noon to 1pm ET Open Discussion FDA Draft Guidance: General Considerations for the Use of New Approach Methodologies in Drug Development

  • 1.  April 29 noon to 1pm ET Open Discussion FDA Draft Guidance: General Considerations for the Use of New Approach Methodologies in Drug Development

    Community Leadership
    Posted an hour ago

    Hosted by the AAPS NAM Subcommittee, NAM Working Group, and Regulatory Science Community (Gene and Cell Therapy Product team)

    The AAPS NAM Subcommittee, NAM Working Group, and Regulatory Science Community are convening an Open Scientific Discussion to discuss FDA's newly released draft guidance, General Considerations for the Use of New Approach Methodologies in Drug Development (Docket No. FDA-2025-D-6131), published March 19, 2026. To review the draft guidance directly: FDA guidance document: https://www.fda.gov/media/191589/download. Click or tap if you trust this link." data-linkindex="1" target="_blank" rel="noopener">https://www.fda.gov/media/191589/download 

    This is an open invitation - if you work in NAMs, nonclinical safety, regulatory science, drug development tools, in vitro/in silico methods, or adjacent areas, your voice matters. We want to hear from you.

    📅 Date: Wednesday, April 29, 2026 🕛 Time: 12:00 PM – 1:00 PM ET 📍 Format: Virtual 🔗 Connection details: Microsoft Teams meeting

    Speakers

    Representatives from the AAPS NAM Subcommittee, NAM Working Group, and Regulatory Science Community will lead the discussion, bringing perspectives across nonclinical science, regulatory strategy, and pharmaceutical development.

    Agenda

    12:00 – 12:05 PM

    Welcome and framing - Regulatory Science Community

    12:05 – 12:20 PM

    Overview of the draft guidance: key provisions and validation framework - NAM Working Group

    12:20 – 12:35 PM

    Regulatory science perspective: opportunities, gaps, and implications for drug development - NAM Subcommittee

    12:35 – 12:55 PM

    Open discussion 

    12:55 – 1:00 PM

    Next steps 

    What We Will Cover

    • Overview and key provisions of the draft guidance
    • Validation framework: context of use, human biological relevance, technical characterization, and fit-for-purpose standards
    • Opportunities and gaps - what the guidance gets right and where clarification is needed


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    Allison Radwick Ph.D.
    Sr Regulatory & Policy Comms Mgr
    USP
    Coatesville PA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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