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GUIDANCE DOCUMENT

Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment Draft Guidance for Industry October 2020

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
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


Docket Number:
FDA-2020-D-1497
Issued by:
Guidance Issuing Office
Oncology Center of Excellence
Center for Drug Evaluation and Research
Center 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.

Questions?

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