Request that FDA order sponsors of immunotherapies for NSCLC to revise their respective Prescribing Information to reflect that patients with ROS1 and RET rearrangements should use targeted therapies as their first line option, relying on its statutory authority under section 505(o)(4) of the FDC Act.
🏛 Food and Drug Administration (FDA)FDA-2026-P-6738
Documents
43
Total comments
2
all analyzed
Comment status
Open
Last activity
Jul 10, 2026
In this docket
Documents
Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
- Other· Jun 16, 2026No comment period
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
- Supporting & Related Material· Jun 16, 2026
