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# Draft Guide on Bladder Cancer Drug Development
- URL: https://www.fdaweb.com/draft-guide-on-bladder-cancer-drug-development/
- Published: 2016-11-18T12:00:00.000Z
- Updated: 2026-09-14T21:48:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137388

*Federal Register* Notice: FDA has made available a draft guidance on “Bacillus Calmette-Guerin (BCG) — Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.” The document is intended to assist sponsors in developing drugs and biologics to treat patients with a high-risk form of bladder cancer. It is also designed to help overcome some of the obstacles in conducting studies needed to establish efficacy of drugs and biologics for these patients. To view the guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM529600.pdf?ref=fdaweb.com). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-11-18/pdf/2016-27762.pdf?ref=fdaweb.com).