Issue Date: August 8, 2024
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Draft
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment : Draft Guidance for Industry
This guidance provides recommendations for the development of drug and biological products for the treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC). This guidance discusses pathological diagnosis and staging, risk stratification, and trial design, including assessment of appropriate clinical endpoints. This guidance, when finalized, will replace the final guidance titled BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment published in February 2018.
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