Event

Accelerating Product Development for Pediatric Systemic Lupus Erythematosus (SLE)

Thursday, July 30, 2026
9:00 a.m.-5:00 p.m.
FDA White Oak Campus, Silver Spring Maryland
M-CERSI
cersi@umd.edu

Workshop Location
FDA White Oak Campus
Building 31, Conference Center, The Great Room (Room 1503)
10903 New Hampshire Ave.
Silver Spring, MD 20993

​Organized By
CDER Office of New Drugs, Division of Pediatrics and Maternal Health
M-CERSI

​Background
Systemic lupus erythematosus (SLE) is a chronic, multisystem autoimmune disease characterized by inflammation, autoantibody production, and alternating periods of disease flares and remission. Approximately 10–20% of cases have onset during childhood. Currently, only one biologic therapy is approved for pediatric SLE, leaving a substantial unmet need for additional safe and effective treatment options.

​Conducting clinical trials in pediatric SLE presents several challenges, including a small patient population, limited specialized centers, and difficulties with recruitment and retention. In addition, there is a need to evaluate how existing data, often from adult SLE studies, may be appropriately extrapolated to pediatric populations to streamline drug development and reduce the burden of clinical research in pediatric patients with SLE to ensure timely availability of safe and effective therapies in this population.

​Agenda
The full agenda is available here.

Registration 
To register, please click this link 

​Visiting the FDA Campus
Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map.

​Virtual Attendance Information
This workshop will be hybrid. The Zoom link will be provided to all registered attendees via email before the workshop.

​Food & Drink
Attendees may bring their own food and drink; however, the FDA cannot guarantee the use of a refrigerator or microwave. Restaurants near the FDA White Oak campus are available, but before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening.

​Accessibility
The FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email Meshaun Payne or Kerri-Ann Jennings at least 14 days before a public meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.

​Contact
For additional details, contact Meshaun Payne or Kerri-Ann Jennings.