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# BCG Treatment Development Guidance
- URL: https://www.fdaweb.com/bcg-treatment-development-guidance/
- Published: 2024-08-08T12:00:00.000Z
- Updated: 2026-09-14T14:37:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157533

FDA has published a draft guidance, *BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drug and Biological Products for Treatment*, with recommendations for developing drug and biological products to treat patients with bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer. The [document](ttps://www.fda.gov/media/101468/download) is intended for drug sponsors, the academic community, and other interested parties, FDA says. It discusses pathological diagnosis and staging, risk stratification, and trial design, including assessment of appropriate clinical endpoints.

When finalized, the guidance will replace a 2/2018 final guidance.