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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

comment_end_date
A FULL UTC INSTANT, not a calendar date, despite the column name: '2026-08-29T03:59:59Z' is 11:59:59 PM EASTERN on 2026-08-28. Federal comment periods close at 11:59:59 PM Eastern, so the UTC calendar date is ONE DAY LATER than the official deadline on every end-of-day close — 444,689 of the 444,690 populated rows (measured 2026-09-06). Convert to America/New_York before presenting a deadline, and compare with julianday(comment_end_date) > julianday('now'): a plain > datetime('now') is a TEXT comparison between two different formats and keeps already-closed dockets matching for up to ~20 hours. The sibling column on open_comments.documents WAS corrected to an Eastern calendar date (queue #498); this one is unchanged and still an instant — the two databases do not agree on grain. (queue #644)
comment_start_date
A FULL UTC INSTANT, not a calendar date, despite the column name — same grain as comment_end_date on this table. Convert to America/New_York before presenting it. (queue #644)

8 rows where docket_id = "FDA-2026-P-3632" sorted by posted_date descending

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document_type 3

  • Other 4
  • Supporting & Related Material 3
  • Notice 1

posted_year 1

  • 2026 8

agency_id 1

  • FDA 8
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-3632-0008 FDA Requests that the FDA to determine that PRALIDOXIME CHLORIDE (AUTOINJECTOR) 600 mg/2 mL intramuscular solution, (NDA 018986) from Meridian Medical Technologies Inc. was not discontinued or withdrawn due to safety or efficacy reasons. FDA-2026-P-3632 Response Letter Other Response(s) 2026-10-06T04:00:00Z 2026 10 2026-10-06T04:00:00Z   2026-10-07T00:05:31Z   0 0 09000064b963a03e
FDA-2026-P-3632-0007 FDA Requests that the FDA to determine that PRALIDOXIME CHLORIDE (AUTOINJECTOR) 600 mg/2 mL intramuscular solution, (NDA 018986) from Meridian Medical Technologies Inc. was not discontinued or withdrawn due to safety or efficacy reasons. FDA-2026-P-3632 Determination PRALIDOXIME CHLORIDE (Autoinjector) (Pralidoxime Chloride) Solution, 600 Milligrams/2 Milliliters (300 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2026-10-06T04:00:00Z 2026 10 2026-10-06T04:00:00Z   2026-10-06T18:37:10Z 2026-20442 0 0 09000064b962e6a8
FDA-2026-P-3632-0006 FDA Requests that the FDA to determine that PRALIDOXIME CHLORIDE (AUTOINJECTOR) 600 mg/2 mL intramuscular solution, (NDA 018986) from Meridian Medical Technologies Inc. was not discontinued or withdrawn due to safety or efficacy reasons. FDA-2026-P-3632 Interim Response Other Letter(s) 2026-09-17T04:00:00Z 2026 9 2026-09-17T04:00:00Z   2026-09-17T21:58:55Z   0 0 09000064b95869bf
FDA-2026-P-3632-0003 FDA Requests that the FDA to determine that PRALIDOXIME CHLORIDE (AUTOINJECTOR) 600 mg/2 mL intramuscular solution, (NDA 018986) from Meridian Medical Technologies Inc. was not discontinued or withdrawn due to safety or efficacy reasons. FDA-2026-P-3632 Attachment 1 Supporting & Related Material Background Material 2026-04-02T04:00:00Z 2026 4     2026-04-03T01:19:48Z   0 0 09000064b924bf7c
FDA-2026-P-3632-0001 FDA Requests that the FDA to determine that PRALIDOXIME CHLORIDE (AUTOINJECTOR) 600 mg/2 mL intramuscular solution, (NDA 018986) from Meridian Medical Technologies Inc. was not discontinued or withdrawn due to safety or efficacy reasons. FDA-2026-P-3632 Citizen Petition from Premier Research International LLC Other Citizen Petition 2026-04-02T04:00:00Z 2026 4 2026-04-02T04:00:00Z   2026-04-03T01:19:39Z   1 0 09000064b924cd42
FDA-2026-P-3632-0004 FDA Requests that the FDA to determine that PRALIDOXIME CHLORIDE (AUTOINJECTOR) 600 mg/2 mL intramuscular solution, (NDA 018986) from Meridian Medical Technologies Inc. was not discontinued or withdrawn due to safety or efficacy reasons. FDA-2026-P-3632 Attachment 2 Supporting & Related Material Background Material 2026-04-02T04:00:00Z 2026 4     2026-04-03T01:19:52Z   0 0 09000064b924bf7d
FDA-2026-P-3632-0002 FDA Requests that the FDA to determine that PRALIDOXIME CHLORIDE (AUTOINJECTOR) 600 mg/2 mL intramuscular solution, (NDA 018986) from Meridian Medical Technologies Inc. was not discontinued or withdrawn due to safety or efficacy reasons. FDA-2026-P-3632 Acknowledgement Letter from FDA DMB to Premier Research International, LLC Other Acknowledgement Letter/Receipt 2026-04-02T04:00:00Z 2026 4 2026-04-02T04:00:00Z   2026-04-03T01:19:44Z   0 0 09000064b924cd44
FDA-2026-P-3632-0005 FDA Requests that the FDA to determine that PRALIDOXIME CHLORIDE (AUTOINJECTOR) 600 mg/2 mL intramuscular solution, (NDA 018986) from Meridian Medical Technologies Inc. was not discontinued or withdrawn due to safety or efficacy reasons. FDA-2026-P-3632 Attachment 3 Supporting & Related Material Background Material 2026-04-02T04:00:00Z 2026 4     2026-07-12T10:05:02Z   0 0 09000064b924bf7e

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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;
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