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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

9 rows where docket_id = "FDA-2018-N-3771" sorted by posted_date descending

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

posted_year 5

  • 2020 3
  • 2023 3
  • 2018 1
  • 2019 1
  • 2022 1

document_type 2

  • Notice 7
  • Other 2

agency_id 1

  • FDA 9
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2018-N-3771-0009 FDA None FDA-2018-N-3771 Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989; Guidance for Industry; Availability. Notice Notice of Availability 2023-09-15T04:00:00Z 2023 9 2023-09-15T04:00:00Z   2023-09-15T13:29:21Z 2023-20014 0 0 0900006485fada46
FDA-2018-N-3771-0010 FDA None FDA-2018-N-3771 Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry Other Guidance 2023-09-15T04:00:00Z 2023 9 2023-09-15T04:00:00Z   2024-11-07T00:52:18Z   1 0 0900006485fb00fb
FDA-2018-N-3771-0008 FDA None FDA-2018-N-3771 Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability Notice Notice of Availability 2023-02-02T05:00:00Z 2023 2 2023-02-02T05:00:00Z   2023-02-02T14:30:15Z 2023-02156 0 0 090000648562c144
FDA-2018-N-3771-0007 FDA None FDA-2018-N-3771 Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability Notice Notice of Availability 2022-04-21T04:00:00Z 2022 4 2022-04-21T04:00:00Z   2022-04-21T13:18:27Z 2022-08499 0 0 0900006485029c13
FDA-2018-N-3771-0004 FDA None FDA-2018-N-3771 Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request Notice Notice of Availability 2020-10-21T04:00:00Z 2020 10 2020-10-21T04:00:00Z 2020-12-22T04:59:59Z 2020-12-19T02:01:52Z 2020-23290 0 0 090000648491f0d0
FDA-2018-N-3771-0005 FDA None FDA-2018-N-3771 Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry Other Guidance 2020-10-21T04:00:00Z 2020 10 2020-10-21T04:00:00Z   2023-09-15T14:11:15Z   0 0 090000648491f204
FDA-2018-N-3771-0003 FDA None FDA-2018-N-3771 Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability Notice Notice of Availability 2020-08-06T04:00:00Z 2020 8 2020-08-06T04:00:00Z   2020-08-06T13:19:04Z 2020-17113 0 0 09000064847dd043
FDA-2018-N-3771-0002 FDA None FDA-2018-N-3771 Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments Notice Notice of Availability 2019-08-07T04:00:00Z 2019 8 2019-08-07T04:00:00Z   2019-08-08T14:33:13Z 2019-16878 0 0 0900006483e066e4
FDA-2018-N-3771-0001 FDA None FDA-2018-N-3771 Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability Notice Notice of Availability 2018-11-19T05:00:00Z 2018 11 2018-11-19T05:00:00Z   2018-11-19T14:51:02Z 2018-25128 0 0 09000064838e674f

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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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