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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

3 rows where docket_id = "FDA-2003-P-0333" and posted_year = 2003 sorted by posted_date descending

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

posted_year 1

  • 2003 · 3 ✖

document_type 1

  • Other 3

agency_id 1

  • FDA 3
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2003-P-0333-0003 FDA To Regulate Recombinant and any Other Previously Unlicensed Endotoxin Detection Tests for Validation, In-Process and Finished Product Endotoxin Testing of Drugs, Biological Products and Medical Devices in Accordance With the Same Requirements That Have Been Applied to Limulus Amebocyte Lysate (LAL) Endotoxin Detection Tests for the Past 30 years-CLOSED FDA-2003-P-0333 Letter from FDA CBER to Hyman, Phelps & McNamara Other LET-Letter 2003-12-10T05:00:00Z 2003 12 2003-12-08T05:00:00Z   2024-10-23T18:40:43Z   0 0 0900006480495e67
FDA-2003-P-0333-0001 FDA To Regulate Recombinant and any Other Previously Unlicensed Endotoxin Detection Tests for Validation, In-Process and Finished Product Endotoxin Testing of Drugs, Biological Products and Medical Devices in Accordance With the Same Requirements That Have Been Applied to Limulus Amebocyte Lysate (LAL) Endotoxin Detection Tests for the Past 30 years-CLOSED FDA-2003-P-0333 Unsigned Acknowledgment Letter from FDA DMB to Cape Cod, Inc. Other Acknowledgement Letter/Receipt 2003-06-18T04:00:00Z 2003 6 2003-06-18T04:00:00Z   2024-10-23T18:23:00Z   0 0 0900006480495dfc
FDA-2003-P-0333-0002 FDA To Regulate Recombinant and any Other Previously Unlicensed Endotoxin Detection Tests for Validation, In-Process and Finished Product Endotoxin Testing of Drugs, Biological Products and Medical Devices in Accordance With the Same Requirements That Have Been Applied to Limulus Amebocyte Lysate (LAL) Endotoxin Detection Tests for the Past 30 years-CLOSED FDA-2003-P-0333 Acknowledgment Letter from FDA DMB to Cape Cod, Inc. Other Acknowledgement Letter/Receipt 2003-06-18T04:00:00Z 2003 6 2003-06-18T04:00:00Z   2024-10-23T18:27:24Z   0 0 0900006480495e5a

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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);
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