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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

14 rows where docket_id = "FDA-2015-D-4750" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-D-4750-0528 FDA None FDA-2015-D-4750 Stakeholder Meeting Summary APC Final2 Other Summary (SUM) 2023-03-27T04:00:00Z 2023 3 2023-03-27T04:00:00Z   2023-03-27T18:33:47Z   0 0 090000648586cdbe
FDA-2015-D-4750-0527 FDA None FDA-2015-D-4750 APC and OFA - FDA Meeting Summary Memorandum - 11-15-21 Other Memorandum 2023-03-23T04:00:00Z 2023 3 2023-03-23T04:00:00Z   2023-03-23T15:34:38Z   0 0 0900006485833052
FDA-2015-D-4750-0438 FDA None FDA-2015-D-4750 The ‘‘Deemed To Be a License’’ Provision of the Biologics Price Competition and Innovation Act: Questions and Answers; Guidance for Industry; Availability Notice Notice of Availability 2020-03-05T05:00:00Z 2020 3 2020-03-05T05:00:00Z   2020-03-05T13:45:14Z 2020-04537 0 0 09000064843ed60b
FDA-2015-D-4750-0439 FDA None FDA-2015-D-4750 The "Deemed To Be a License" Provision of the BPCI Act; Questions and Answers; Guidance for Industry Other Guidance 2020-03-05T05:00:00Z 2020 3 2020-03-05T05:00:00Z   2026-03-02T10:00:13Z   1 0 09000064843eda81
FDA-2015-D-4750-0026 FDA None FDA-2015-D-4750 Request for Extension from Foley & Lardner LLP Other Request for Extension 2019-02-08T05:00:00Z 2019 2 2019-02-08T05:00:00Z   2019-02-08T21:39:11Z   0 0 0900006483a582de
FDA-2015-D-4750-0027 FDA None FDA-2015-D-4750 Request for Extension from Foley & Lardner, LLP Other Request for Extension 2019-02-08T05:00:00Z 2019 2 2019-02-08T05:00:00Z   2019-02-08T21:56:15Z   0 0 0900006483a5830a
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FDA None FDA-2015-D-4750 The ‘‘Deemed to be a License’’ Provision of the BPCI Act: Questions and Answers; Draft Guidance for Industry; Availability; Request for Comments on Preliminary List of Affected Applications Notice Notice of Availability 2018-12-12T05:00:00Z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FDA-2015-D-4750-0022 FDA None FDA-2015-D-4750 Draft Guidance for Industry The "Deemed to be a License" Provision of the BPCI Act Questions and Answers Guidance for Industry Other Guidance 2018-12-12T05:00:00Z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
FDA-2015-D-4750-0012 FDA None FDA-2015-D-4750 Attachment 1 Draft Guidance " Implementation of the ''Deemed to be a License'' Provision of the Biologics Price Competition and Innovation Act of 2009" re: Comment from Biotechnology Innovation Organization Supporting & Related Material Background Material 2016-06-07T04:00:00Z 2016 6     2016-06-07T14:02:24Z   0 0 0900006482018d24
FDA-2015-D-4750-0001 FDA None FDA-2015-D-4750 Implementation of the ‘‘Deemed To Be a License’’ Provision of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability and Request for Comments Notice Notice of Availability 2016-03-14T04:00:00Z 2016 3 2016-03-14T04:00:00Z 2016-05-14T03:59:59Z 2016-05-14T04:00:39Z 2016-05626 0 0 0900006481ebf885
FDA-2015-D-4750-0002 FDA None FDA-2015-D-4750 Draft Guidance for Industry: Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 Other Guidance 2016-03-14T04:00:00Z 2016 3 2016-03-14T04:00:00Z   2024-11-12T05:56:21Z   1 0 0900006481ebffbd

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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;