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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-2017-D-3101" sorted by posted_date descending

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Suggested facets: title, 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

  • 2017 4
  • 2022 2
  • 2025 2

document_type 2

  • Notice 4
  • Other 4

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2017-D-3101-0022 FDA None FDA-2017-D-3101 Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions; Guidance for Industry; Availability Notice Notice of Availability 2025-06-16T04:00:00Z 2025 6 2025-06-16T04:00:00Z   2025-06-16T17:46:03Z 2025-10922 0 0 09000064b8e12d9a
FDA-2017-D-3101-0023 FDA None FDA-2017-D-3101 ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions; Guidance for Industry - Final Guidance Other Guidance 2025-06-16T04:00:00Z 2025 6 2025-06-16T04:00:00Z   2025-06-16T18:00:16Z   1 0 09000064b8e12f76
FDA-2017-D-3101-0018 FDA None FDA-2017-D-3101 Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions; Draft Guidance for Industry; Availability Other Guidance 2022-12-05T05:00:00Z 2022 12 2022-12-05T05:00:00Z 2023-03-07T04:59:59Z 2025-06-16T18:00:48Z   0 0 090000648551989c
FDA-2017-D-3101-0017 FDA None FDA-2017-D-3101 Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions; Draft Guidance for Industry; Availability Notice Notice of Availability 2022-12-05T05:00:00Z 2022 12 2022-12-05T05:00:00Z   2022-12-05T13:29:25Z 2022-26412 0 0 09000064855196fa
FDA-2017-D-3101-0011 FDA None FDA-2017-D-3101 Abbreviated New Drug Applications: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence); Draft Guidance for Industry; Availability Notice Guidance 2017-11-06T05:00:00Z 2017 11 2017-11-06T05:00:00Z 2018-02-06T04:59:59Z 2017-11-06T14:47:02Z 2017-24099 0 0 0900006482c48219
FDA-2017-D-3101-0012 FDA None FDA-2017-D-3101 ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry Other Guidance 2017-11-06T04:00:00Z 2017 11 2017-11-06T04:00:00Z 2018-02-06T04:59:59Z 2025-06-16T18:01:07Z   0 0 0900006482c4b344
FDA-2017-D-3101-0002 FDA None FDA-2017-D-3101 ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions Guidance for Industry Other Guidance 2017-06-20T04:00:00Z 2017 6 2017-06-20T04:00:00Z 2017-09-19T03:59:59Z 2019-06-18T16:16:08Z   0 0 09000064826f71e8
FDA-2017-D-3101-0001 FDA None FDA-2017-D-3101 Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Associated with Priority Submissions; Draft Guidance for Industry; Availability Notice Notice of Availability 2017-06-20T04:00:00Z 2017 6 2017-06-20T04:00:00Z 2017-09-19T03:59:59Z 2017-06-30T13:04:39Z 2017-12836 0 0 09000064826f5d6c

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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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