Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics | Federal Regulations · Congress.wiki

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

Comments

Description

OPEN

Key Dates

Comment Period OpensMay 11, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	Appendix V - Reinhardt L, et al. Systematic mapping of fluoroquinolone off-target effects in human cells reveals mitochondrial and metabolic pathway interactions. Angew Chem Int Ed. 2025.	May 11, 2026	--

Comment Statistics

Total Comments

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