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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-2004-D-0301" sorted by posted_date descending

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

posted_year 3

  • 2004 4
  • 2006 2
  • 2023 2

document_type 3

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

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2004-D-0301-0016 FDA Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV' FDA-2004-D-0301 Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry; Availability Notice Notice of Availability 2023-08-03T04:00:00Z 2023 8     2023-08-03T15:26:30Z 2023-16557 0 0 0900006485db567f
FDA-2004-D-0301-0015 FDA Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV' FDA-2004-D-0301 Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under PEPFAR - Guidance for Industry DRAFT GUIDANCE Other Guidance 2023-08-01T04:00:00Z 2023 8 2023-08-01T04:00:00Z 2023-11-02T03:59:59Z 2024-11-07T00:32:52Z   1 0 0900006485d9dba5
FDA-2004-D-0301-0006 FDA Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV' FDA-2004-D-0301 Guidance for Industry on Fixed Dose Combina.tions, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV; Availability Notice NAD-Notice of Availability of Data 2006-10-18T04:00:00Z 2006 10 2006-10-17T04:00:00Z 2007-10-19T03:59:59Z 2020-09-10T17:30:49Z   0 0 0900006480472ddf
FDA-2004-D-0301-0005 FDA Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV' FDA-2004-D-0301 Guidance for Industry Fixed Dose Combinations, Co-Packaged Drug Products, and Single-EntityVersions of Previously Approved Antiretrovirals for the Treatment of HIV Other Guidance 2006-10-18T04:00:00Z 2006 10     2020-09-10T19:00:16Z   0 0 0900006480472dde
FDA-2004-D-0301-0004 FDA Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV' FDA-2004-D-0301 Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV; Availability Notice NAD-Notice of Availability of Data 2004-05-20T04:00:00Z 2004 5 2004-05-17T04:00:00Z 2004-07-20T03:59:59Z 2020-09-10T17:29:38Z   0 0 0900006480472dd4
FDA-2004-D-0301-0001 FDA Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV' FDA-2004-D-0301 FDA Notice NAD-Notice of Availability of Data 2004-05-20T04:00:00Z 2004 5 2004-05-17T04:00:00Z 2004-07-20T03:59:59Z 2020-09-19T20:34:04Z   0 0 0900006480472dc9
FDA-2004-D-0301-0002 FDA Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV' FDA-2004-D-0301 Guidance for Industry Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV - DRAFT GUIDANCE Other Guidance 2004-05-20T04:00:00Z 2004 5     2020-09-15T01:02:11Z   0 0 0900006480472dd0
FDA-2004-D-0301-0003 FDA Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV' FDA-2004-D-0301 Guidance Supporting & Related Material GDL-Guidance 2004-05-20T04:00:00Z 2004 5     2008-04-12T00:35:45Z   0 0 0900006480472dd3

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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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