Contemporary Issues in Non-Muscle Invasive Bladder Cancer (NMIBC) Trial Design and Interpretation May 18, 2026

Workshop | Mixed

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• Date: May 18, 2026
• Time: 12:30 p.m. - 4:30 p.m. ET
• Location: FDA, White Oak Campus, The Great Room; Attend In Person or Online; Virtual: Via YouTube ; In Person: FDA White Oak Campus; 10903 New Hampshire Ave; Building 31, Room 1503; Silver Spring, MD 20993; United States

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Background:

The Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) is holding a workshop to discuss several topics related to the ongoing evolution of the landscape of therapies for NMIBC, including the similarities and differences, from the perspectives of molecular biology, clinical pathology, urology, and medical oncology, of the two major types of histology [papillary and carcinoma in situ (CIS)] observed in NMIBC as well as the current state of the Bacillus Calmette-Guérin (BCG) shortage and implications of this shortage for clinical trial design.

Meeting Goals:

• Discuss the similarities and differences between the two types of histology (papillary and CIS) observed in NMIBC and implications for the demonstration of efficacy in clinical trials.
• Examine the current state of the BCG shortage and the impact on clinical trial design.

Registration is required for this free hybrid public workshop with limited seating for in-person attendees. 

• In-Person Registration
• Virtual Registration [Not live]

Public Meeting Information | FDA
Getting to the FDA | FDA
Visitor Parking and Campus Map | FDA

Workshop Materials:

• Agenda
• Biographies

Contact: 

Angela James, MSN, RN
Senior Health Scientist
Oncology Center of Excellence (OCE)
Angela.james@fda.hhs.gov