All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2026-P-5116
Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics
Documents
9
Comments
183
Description
OPEN
Key Dates
Comment Period OpensMay 11, 2026
Documents
| Type | Title | Status |
|---|---|---|
Other |
Comment Statistics
Total Comments
183
Keywords
CDER
Citizen Petition
issue appropriate labeling and risk
communication requirements for
systemic fluoroquinolone antibiotics
risk of serious adverse effects
that may occur together
across multiple systems
Data from Regulations.gov