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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

11 rows where docket_id = "FDA-2024-P-3293" sorted by posted_date descending

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

document_type 2

  • Supporting & Related Material 6
  • Other 5

posted_year 1

  • 2024 11

agency_id 1

  • FDA 11
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2024-P-3293-0011 FDA None FDA-2024-P-3293 Final Response Letter from FDA CDER to Newcastle Bioscience LLC Other Approval 2024-12-27T05:00:00Z 2024 12 2024-12-27T05:00:00Z   2024-12-27T20:32:43Z   0 0 090000648688ca84
FDA-2024-P-3293-0009 FDA None FDA-2024-P-3293 Suitability Petition Amendment from Newcastle Bioscience LLC Other Amendment 2024-08-01T04:00:00Z 2024 8 2024-08-01T04:00:00Z   2024-08-01T20:31:12Z   0 0 09000064866136a4
FDA-2024-P-3293-0010 FDA None FDA-2024-P-3293 Attachment 1 - Petition Letter Updated Supporting & Related Material Background Material 2024-08-01T04:00:00Z 2024 8     2024-08-01T20:31:36Z   0 0 09000064866136aa
FDA-2024-P-3293-0008 FDA None FDA-2024-P-3293 Completeness Assessment Correspondence Other Assessment Document or Analysis 2024-07-30T04:00:00Z 2024 7 2024-07-30T04:00:00Z   2024-08-29T17:07:04Z   0 0 090000648660e301
FDA-2024-P-3293-0005 FDA None FDA-2024-P-3293 Lacosamide 2024 A3 Supporting & Related Material Background Material 2024-07-15T04:00:00Z 2024 7     2024-07-15T12:34:39Z   0 0 09000064865ec7b9
FDA-2024-P-3293-0006 FDA None FDA-2024-P-3293 Lacosamide 2024 A4 Supporting & Related Material Background Material 2024-07-15T04:00:00Z 2024 7     2024-07-15T12:34:52Z   0 0 09000064865ec7bc
FDA-2024-P-3293-0003 FDA None FDA-2024-P-3293 Lacosamide 2024 A1 Supporting & Related Material Background Material 2024-07-15T04:00:00Z 2024 7     2024-07-15T12:34:08Z   0 0 09000064865ec7b7
FDA-2024-P-3293-0002 FDA None FDA-2024-P-3293 Acknowledgment Letter from FDA DMS to Newcastle Bioscience LLC Other Acknowledgement Letter/Receipt 2024-07-15T04:00:00Z 2024 7 2024-07-15T04:00:00Z   2024-07-15T12:33:52Z   0 0 09000064865ec799
FDA-2024-P-3293-0004 FDA None FDA-2024-P-3293 Lacosamide 2024 A2 Supporting & Related Material Background Material 2024-07-15T04:00:00Z 2024 7     2024-07-15T12:34:21Z   0 0 09000064865ec7b8
FDA-2024-P-3293-0007 FDA None FDA-2024-P-3293 Lacosamide 2024 A5 Supporting & Related Material Background Material 2024-07-15T04:00:00Z 2024 7     2024-07-15T12:35:10Z   0 0 09000064865ec8a8
FDA-2024-P-3293-0001 FDA None FDA-2024-P-3293 Suitability Petition from Newcastle Bioscience LLC Other Petition(s) 2024-07-12T04:00:00Z 2024 7 2024-07-12T04:00:00Z   2024-12-26T18:45:26Z   0 0 09000064865ec379

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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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