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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

5 rows where docket_id = "FDA-2015-D-4750" and posted_year = 2018 sorted by posted_date descending

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Suggested facets: 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)

document_type 2

  • Other 3
  • Notice 2

posted_year 1

  • 2018 · 5 ✖

agency_id 1

  • FDA 5
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-D-4750-0021 FDA None FDA-2015-D-4750 The ‘‘Deemed to be a License’’ Provision of the BPCI Act: Questions and Answers; Draft Guidance for Industry; Availability; Request for Comments on Preliminary List of Affected Applications Notice Notice of Availability 2018-12-12T05:00:00Z 2018 12 2018-12-12T05:00:00Z 2019-02-12T04:59:59Z 2024-11-12T22:51:55Z 2018-26855 1 0 0900006483987c31
FDA-2015-D-4750-0022 FDA None FDA-2015-D-4750 Draft Guidance for Industry The "Deemed to be a License" Provision of the BPCI Act Questions and Answers Guidance for Industry Other Guidance 2018-12-12T05:00:00Z 2018 12 2018-12-12T05:00:00Z 2019-02-12T04:59:59Z 2024-11-12T22:52:01Z   1 0 0900006483988ea0
FDA-2015-D-4750-0020 FDA None FDA-2015-D-4750 Interpretation of the ‘‘Deemed To Be a License’’ Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability Notice Notice of Availability 2018-12-12T05:00:00Z 2018 12 2018-12-12T05:00:00Z   2018-12-12T15:17:09Z 2018-26854 0 0 0900006483987aea
FDA-2015-D-4750-0023 FDA None FDA-2015-D-4750 01-Final Guidance for Industry Interpretation of the Deemed to be a License Provision of the Biologics Price Competition and Innovation Act of 2009 Other Guidance 2018-12-12T05:00:00Z 2018 12 2018-12-12T05:00:00Z   2024-11-12T22:53:33Z   1 0 0900006483988e9e
FDA-2015-D-4750-0019 FDA None FDA-2015-D-4750 Memorandum of Meeting with Mylan Other Memorandum 2018-08-31T04:00:00Z 2018 8 2018-08-31T04:00:00Z   2018-08-31T16:17:36Z   0 0 09000064836875b1

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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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