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EDDO Combination Product Control Strategies and Best Practices

Thursday, November 13, 2025
2:30 PM - 3:30 PM East Coast USA Time

    Moderator(s)

  • Rumi Young

    Director, Regulatory Policy
    Novo Nordisk

    • Speaker(s)

  • Anna Karina Busch

    Regulatory Affairs Specialist
    Novo Nordisk

  • Ashley Boam

    Director Office of Policy for Pharmaceutical Quality, Office of Policy, Center for Drug Evaluation and Research (CDER)
    FDA

  • Susan Clemmons

    Associate Director, CMC Devices
    GSK

  • Willy Liou

    Director of Regulatory Affairs
    Amgen

  • Shruti Mistry

    Assistant Director, Injection Devices Team, Center for Devices andRadiological Health (CDRH)
    FDA (Virtual)

How do you demonstrate that your combination product will meet its specifications in a premarket application? In this session, a panel of experts will share some challenges of developing a combination product control strategy in a pharmaceutical development framework, lifecycle management, and global trends. Highlights include specific recommendations from the FDA EDDO guidance, determining which EDDOs to place on release and/or stability testing, factors that determine effective design and/or manufacturing upstream control for EDDOs, and more.