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# Two Stakeholder Comments on BCG-Unresponsive Guide
- URL: https://www.fdaweb.com/two-stakeholder-comments-on-bcg-unresponsive-guide/
- Published: 2024-10-08T12:00:00.000Z
- Updated: 2026-09-14T14:43:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157941

Johnson & Johnson says that since an FDA draft guidance on Bacillus Calmette-Guerin-Unresponsive Nonmuscle Invasive Bladder Cancer treatment development will replace a 2/2018 guidance when it is finalized, and ongoing trials were designed based on recommendations in the 2018 version, it would be helpful for FDA to include a statement in the new draft that once finalized the new guidance will apply to new clinical trials. The company comment [letter](https://www.regulations.gov/comment/FDA-2018-D-0342-0008?ref=fdaweb.com) also contains specific line-by-line recommendations.

In its [response](https://www.regulations.gov/comment/FDA-2018-D-0342-0007?ref=fdaweb.com), GlaxoSmithKline comments on the Development Program section of the draft, with recommendations addressing early product development and late product development.