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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

8 rows where docket_id = "FDA-2025-P-7376" sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, comment_start_date, open_for_comment, posted_date (date), comment_start_date (date), last_modified (date)

posted_year 2

  • 2025 6
  • 2026 2

document_type 2

  • Other 4
  • Supporting & Related Material 4

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2025-P-7376-0008 FDA None FDA-2025-P-7376 Completeness Assessment Correspondence Other Assessment Document or Analysis 2026-02-10T05:00:00Z 2026 2 2026-02-10T05:00:00Z   2026-02-11T00:17:09Z   0 0 09000064b919f2bb
FDA-2025-P-7376-0007 FDA None FDA-2025-P-7376 Amendment from WhiteOak Group, LLC Other Ammendment 2026-01-27T05:00:00Z 2026 1     2026-02-02T21:09:43Z   0 0 09000064b91858a8
FDA-2025-P-7376-0001 FDA None FDA-2025-P-7376 Suitability Petition from The WhiteOak Group, LLC (on behalf of Hybio Pharmaceutical Co., Ltd.) Other Petition(s) 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z   2025-12-30T01:32:13Z   1 0 09000064b910b8b8
FDA-2025-P-7376-0006 FDA None FDA-2025-P-7376 Attachment 4 Supporting & Related Material Background Material 2025-12-29T05:00:00Z 2025 12     2025-12-30T01:36:41Z   0 0 09000064b910b481
FDA-2025-P-7376-0002 FDA None FDA-2025-P-7376 Acknowledgement Letter from FDA DMB to The WhiteOak Group, LLC (on behalf of Hybio Pharmaceutical Co., Ltd.) Other Acknowledgement Letter/Receipt 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z   2025-12-30T01:36:19Z   0 0 09000064b910b8c1
FDA-2025-P-7376-0003 FDA None FDA-2025-P-7376 Attachment 1 Supporting & Related Material Background Material 2025-12-29T05:00:00Z 2025 12     2025-12-30T01:36:34Z   0 0 09000064b910b47a
FDA-2025-P-7376-0005 FDA None FDA-2025-P-7376 Attachment 3 Supporting & Related Material Background Material 2025-12-29T05:00:00Z 2025 12     2025-12-30T01:36:39Z   0 0 09000064b910b480
FDA-2025-P-7376-0004 FDA None FDA-2025-P-7376 Attachment 2 Supporting & Related Material Background Material 2025-12-29T05:00:00Z 2025 12     2025-12-30T01:36:37Z   0 0 09000064b910b47e

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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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