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Guidance Issuing OfficeOncology Center of ExcellenceCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This guidance provides recommendations to sponsors regarding the development of drugs and biologics, regulated by CDER and CBER for the adjuvant treatment of muscle-invasive bladder cancer. The guidance includes recommendations regarding eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free survival (DFS), and interpretation of trial results. Although FDA may consider endpoints other than DFS for the adjuvant treatment of muscle-invasive bladder cancer, this guidance is focused on clinical trials with DFS as the primary efficacy endpoint.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-1497.