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April 29 noon to 1pm ET Open Discussion FDA Draft Guidance: General Considerations for the Use of New Approach Methodologies in Drug Development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  April 29 noon to 1pm ET Open Discussion FDA Draft Guidance: General Considerations for the Use of New Approach Methodologies in Drug Development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 04-23-2026 17:42

    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Group, and Regulatory Science Community are convening an Open Scientific Discussion to discuss FDA's newly released draft guidance, General Considerations for the Use of New Approach Methodologies in Drug Development (Docket No. FDA-2025-D-6131), published March 19, 2026. To review the draft guidance directly: FDA guidance document: https://www.fda.gov/media/191589/download. 

    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.

    ๐Ÿ“… Date: Wednesday, April 29, 2026 ๐Ÿ•› Time: 12:00 PM โ€“ 1:00 PM ET ๐Ÿ“ Format: Virtual ๐Ÿ”— 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 โ€“ 12:05 PM

     Welcome and framing - Regulatory Science Community

    12:05 โ€“ 12:20 PM

     Overview of the draft guidance: key provisions and validation framework - NAM Working Group

    12:20 โ€“ 12:35 PM

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

    12:35 โ€“ 12:55 PM

     Open discussion 

    12:55 โ€“ 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    • Overview and key provisions of the draft guidance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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  • 2.  RE: 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 26 days ago

    If you like these types of discussions, feel free to reach out to any AAPS Community leaders. The Regulatory Science Community plan to schedule guidance discussions once a quarter and are open to ideas.

    AAPS Initiatives

    โ€“            SAC NAM Subcommittee    Contact Amit Desai [email protected]

    โ€“            NAM Working Group           Contact Vibha Jawa [email protected] or Pooja Khanna [email protected]

    โ€“          2 subteams

    ยป       DMPK - Seema Kumar [email protected] & Jatin Narula [email protected]

    ยป       Immunogenicity &Toxicity Jenny Valentine [email protected] & Kavitha Akula [email protected]

    The NAM Subcommittee and Working Group serve as the central hub for all AAPS NAMs activity.

    AAPS members engaged in NAMs work are encouraged to connect with and contribute through the NAM Subcommittee and Working Group.

    โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€

    CROSS-COMMUNITY COORDINATION

    โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€โ”€

    The Bioanalytical, Pharmaceutical Quality, Regulatory Science, and Translational & Clinical Science Communities are engaging with NAM topics.

    Community members attending NBC encouraged to connect at relevant NBC sessions on May 14, 2026 were noted for continued engagement.

    - "Clinical Mimicry and Drug Discovery on Organ Chips" - Chandrav De, PhD, Wyss Institute at Harvard

    - Keynote: "Strategic Implementation of AI in Regulated Bioanalytical Testing During Clinical Development" - Jean-Claude Marshall, Moderna

    Moderator: Darshana Jani, PhD (she/her/hers) โ€“ Moderna



    ------------------------------
    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.
    ------------------------------