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Final Program


Schedule at a Glance
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Program: Scientific Session
General Topic: Pediatric

Pediatric Rheumatology FDA Updates

Wednesday, October 29, 2025
8:30 AM – 9:30 AM Central Time

    Moderator(s)

  • PL

    Pui Lee, MD, PhD

    Boston Children's Hospital
    Newton, Massachusetts, United States

    Disclosure(s): Pfizer: Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Terminated, January 31, 2025)

    • Session Coordinator(s)

  • Jessica Neely, MD

    UCSF
    San Francisco, California, United States

    Disclosure information not submitted.

  • PL

    Pui Lee, MD, PhD

    Boston Children's Hospital
    Newton, Massachusetts, United States

    Disclosure(s): Pfizer: Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Terminated, January 31, 2025)

In this session, the speakers will discuss the FDA’s approach to ensuring the availability of safe and effective drugs and highlight new initiatives at the FDA relevant to pediatric rheumatology. This session will review the efficacy and safety of recent approvals for the treatment of pediatric rheumatic diseases, the increasing number of biosimilars and interchangeables, and the data to support these approvals.

Learning Objectives:

  • Discuss efficacy and safety of recently approved agents for the treatment of pediatric patients with rheumatic diseases, including mechanisms by which these agents were approved
  • Discuss the FDA’s approach to the development of biosimilar and interchangeable products
  • Discuss barriers for the development new therapies for the pediatric population

Presentations:

  • 8:30 AM – 9:00 AM Central Time
    TBD
  • 9:00 AM – 9:30 AM Central Time
    TBD