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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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15 rows where docket_id = "FDA-2008-N-0424" sorted by posted_date descending

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posted_year 5

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2008-N-0424-0039 FDA None FDA-2008-N-0424 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2020-11-12T05:00:00Z 2020 11 2020-11-12T05:00:00Z   2020-11-12T15:06:25Z 2020-25019 0 0 090000648495a208
FDA-2008-N-0424-0038 FDA None FDA-2008-N-0424 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Safety Information Sharing by Constituent Part Applicants for Combination Products Notice 30 Day Proposed Information Collection 2020-08-05T04:00:00Z 2020 8 2020-08-05T04:00:00Z 2020-09-05T03:59:59Z 2020-08-05T13:47:16Z 2020-17041 0 0 09000064847d721d
FDA-2008-N-0424-0037 FDA None FDA-2008-N-0424 Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Safety Information Sharing by Constituent Part Applicants for Combination Products Notice 60 Day Proposed Information Collection 2020-04-30T04:00:00Z 2020 4 2020-04-30T04:00:00Z 2020-06-30T03:59:59Z 2020-05-01T19:26:19Z 2020-09175 0 0 09000064845283a6
FDA-2008-N-0424-0035 FDA None FDA-2008-N-0424 Final Guidance for Industry and FDA Staff on Postmarketing Safety Reporting for Combination Products; Availability Notice Notice of Availability 2019-07-23T04:00:00Z 2019 7 2019-07-23T04:00:00Z   2019-07-23T17:09:15Z 2019-15595 0 0 0900006483da9f72
FDA-2008-N-0424-0036 FDA None FDA-2008-N-0424 Guidance for Industry on Postmarketing Safety Reporting for Combination Products Other Guidance 2019-07-22T04:00:00Z 2019 7 2019-07-22T04:00:00Z   2024-11-12T23:05:01Z   1 0 0900006483dab261
FDA-2008-N-0424-0034 FDA None FDA-2008-N-0424 Compliance Policy for Combination Product Postmarketing Safety Reporting; Immediately in Effect Guidance for Industry; Availability Rule Correction 2019-04-24T04:00:00Z 2019 4 2019-04-24T04:00:00Z   2019-07-23T11:14:49Z 2019-08284 0 0 0900006483be9a6e
FDA-2008-N-0424-0024 FDA None FDA-2008-N-0424 Immediately in Effect Guidance for Industry; Compliance Policy for Combination Product Postmarketing Safety Reporting; Availability Notice Notice of Availability 2018-03-21T04:00:00Z 2018 3 2018-03-21T04:00:00Z   2019-07-23T11:13:53Z 2018-05688 0 0 0900006483035dd7
FDA-2008-N-0424-0025 FDA None FDA-2008-N-0424 Compliance Policy for Combination Product Postmarketing Safety Reporting Immediately in Effect Guidance for Industry and Food and Drug Administration Staff Other Guidance 2018-03-21T04:00:00Z 2018 3 2018-03-21T04:00:00Z   2024-11-07T01:24:51Z   1 0 09000064830371ce
FDA-2008-N-0424-0023 FDA None FDA-2008-N-0424 Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff DRAFT GUIDANCE Other Guidance 2018-03-21T04:00:00Z 2018 3 2018-03-21T04:00:00Z 2018-06-20T03:59:59Z 2019-10-23T14:45:31Z   0 0 090000648302e3eb
FDA-2008-N-0424-0022 FDA None FDA-2008-N-0424 Postmarketing Safety Reporting for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Proposed Rule GDL Guidance 2018-03-21T04:00:00Z 2018 3 2018-03-21T04:00:00Z 2018-06-20T03:59:59Z 2018-03-21T13:13:54Z 2018-05687 0 0 09000064830356f0
FDA-2008-N-0424-0019 FDA None FDA-2008-N-0424 Postmarketing Safety Reporting for Combination Products Rule Final Rule 2016-12-20T05:00:00Z 2016 12 2016-12-20T05:00:00Z   2016-12-20T15:03:50Z 2016-30485 0 0 0900006482429777
FDA-2008-N-0424-0020 FDA None FDA-2008-N-0424 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION PUBLIC HEARING ON: FDA REGULATION OF COMBINATION PRODUCTS Supporting & Related Material Background Material 2016-12-20T05:00:00Z 2016 12     2016-12-20T16:15:31Z   0 0 090000648242a391
FDA-2008-N-0424-0021 FDA None FDA-2008-N-0424 Regulatory Impact Assessment for Postmarketing Safety Reporting for Combination Products Supporting & Related Material Background Material 2016-12-20T05:00:00Z 2016 12     2016-12-20T17:11:22Z   0 0 090000648242a394
FDA-2008-N-0424-0004 FDA None FDA-2008-N-0424 Postmarketing Safety Reporting for Combination Products; Extension of Comment Period Notice NPR-Notice of Proposed Rule-Making 2009-12-11T05:00:00Z 2009 12 2009-12-11T05:00:00Z 2010-01-30T04:59:59Z 2011-06-11T16:27:47Z E9-29493 0 0 0900006480a692a4
FDA-2008-N-0424-0001 FDA None FDA-2008-N-0424 Postmarketing Safety Reporting for Combination Products Proposed Rule NPR-Notice of Proposed Rule-Making 2009-10-01T04:00:00Z 2009 10 2009-10-01T04:00:00Z 2009-12-31T04:59:59Z 2011-06-11T16:27:47Z E9-23519 0 0 0900006480a34de0

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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;