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# Comments on Bladder Cancer Drug Development Guidance
- URL: https://www.fdaweb.com/comments-on-bladder-cancer-drug-development-guidance/
- Published: 2020-12-03T12:00:00.000Z
- Updated: 2026-09-14T16:38:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148216

Responding to an FDA draft guidance on developing drugs and biologics for adjuvant treatment of bladder cancer, Novartis [says](https://beta.regulations.gov/comment/FDA-2020-D-1496-0006?ref=fdaweb.com) it applauds the agency’s efforts to seek input from stakeholders on actionable policy suggestions that could be implemented in the near-term by CDER Office of New Drugs staff to promote effective drug development programs without compromising regulatory standards for assessing safety and effectiveness. The company says that adding a standardized definition of “disease-free survival” would allow consistent interpretation and analysis of adjuvant bladder cancer clinical trials and facilitate cross-trial comparisons and meta-analyses.

A Pfizer comment [letter](https://beta.regulations.gov/comment/FDA-2020-D-1497-0003?ref=fdaweb.com) provided line-by-line specific suggestions.