Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drug and Biological Products for Treatment; Revised Draft Guidance for Industry; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Bacillus Calmette-Gu[eacute]rin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drug and Biological Products for Treatment." The purpose of this guidance is to assist sponsors in the development of drug and biological products for the treatment of patients with bacillus Calmette-Gu[eacute]rin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC). This draft guidance reflects proposed revisions to the final guidance entitled "BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment," published in February 2018, and incorporates changes based on review experience as well as the evolving landscape of drug development in bladder cancer, as noted by external experts.
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