documents

Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

7 rows where docket_id = "FDA-2026-P-5116" sorted by posted_date descending

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id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2026-P-5116-0007 FDA Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics FDA-2026-P-5116 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. Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-11T23:22:24Z   0 0 09000064b92c88ff
FDA-2026-P-5116-0001 FDA Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics FDA-2026-P-5116 Citizen Petition from Johanna Ihli Other Citizen Petition 2026-05-11T04:00:00Z 2026 5 2026-05-11T04:00:00Z   2026-05-13T09:00:30Z   1 0 09000064b92c9a5d
FDA-2026-P-5116-0002 FDA Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics FDA-2026-P-5116 Acknowledgment Letter from FDA DMB to Johanna Ihli Other Acknowledgement Letter/Receipt 2026-05-11T04:00:00Z 2026 5 2026-05-11T04:00:00Z   2026-05-11T23:21:53Z   0 0 09000064b92c9a61
FDA-2026-P-5116-0005 FDA Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics FDA-2026-P-5116 Appendix III - Hangas A, Aasumets K, Kekäläinen NJ, Paloheinä M, Pohjoismäki JLO, Gerhold JM. Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2. Pharmacol Res. 2018;132:101–110. Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-11T23:22:14Z   0 0 09000064b92c88fd
FDA-2026-P-5116-0003 FDA Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics FDA-2026-P-5116 Appendix I - FDA 2013 Safety Communication (peripheral neuropathy warning) Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-11T23:22:04Z   0 0 09000064b92c88fb
FDA-2026-P-5116-0004 FDA Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics FDA-2026-P-5116 Appendix II - FDA 2015 Joint Advisory Committee Materials (FQAD / multisystem discussion) Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-11T23:22:09Z   0 0 09000064b92c88fc
FDA-2026-P-5116-0006 FDA Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics FDA-2026-P-5116 Appendix IV - Kalghatgi S, Spina CS, Costello JC, et al. Bactericidal antibiotics induce mitochondrial dysfunction and oxidative damage in mammalian cells. Sci Transl Med. 2013;5(192):192ra85. Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-11T23:22:19Z   0 0 09000064b92c88fe

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;