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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

20 rows where docket_id = "FDA-2023-N-0061" sorted by posted_date descending

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

document_type 3

  • Supporting & Related Material 18
  • Other 1
  • Proposed Rule 1

posted_year 1

  • 2024 20

agency_id 1

  • FDA 20
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2023-N-0061-0050 FDA None FDA-2023-N-0061 TAB C - 2013-930-Drug Products-PRIA-FINAL Supporting & Related Material Background Material 2024-11-06T05:00:00Z 2024 11     2024-11-06T17:02:05Z   0 0 0900006486800148
FDA-2023-N-0061-0045 FDA None FDA-2023-N-0061 TAB A - 2013-930-Drug Products-Proposed Rule-ORIGINAL Supporting & Related Material Background Material 2024-11-06T05:00:00Z 2024 11     2024-11-06T17:01:31Z   0 0 0900006486800149
FDA-2023-N-0061-0049 FDA None FDA-2023-N-0061 TAB B - 2013-930-Drug Products-PRIA-TRACK CHANGE FROM ORIGINAL TO FINAL Supporting & Related Material Background Material 2024-11-06T05:00:00Z 2024 11     2024-11-06T17:01:59Z   0 0 0900006486800147
FDA-2023-N-0061-0046 FDA None FDA-2023-N-0061 TAB B - 2013-930-Drug Products-Proposed Rule-TRACK CHANGE FROM ORIGINAL TO FINAL Supporting & Related Material Background Material 2024-11-06T05:00:00Z 2024 11     2024-11-06T17:01:38Z   0 0 090000648680014a
FDA-2023-N-0061-0048 FDA None FDA-2023-N-0061 TAB A - 2013-930-Drug Products-PRIA-ORIGINAL Supporting & Related Material Background Material 2024-11-06T05:00:00Z 2024 11     2024-11-06T17:01:54Z   0 0 0900006486800144
FDA-2023-N-0061-0047 FDA None FDA-2023-N-0061 TAB C - 2013-930-Drug Products-Proposed Rule-FINAL Supporting & Related Material Background Material 2024-11-06T05:00:00Z 2024 11     2024-11-06T17:01:44Z   0 0 090000648680014b
FDA-2023-N-0061-0044 FDA None FDA-2023-N-0061 Memorandum - Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) Other Memorandum 2024-11-06T05:00:00Z 2024 11 2024-11-06T05:00:00Z   2024-11-06T17:00:18Z   0 0 09000064867ffe78
FDA-2023-N-0061-0004 FDA None FDA-2023-N-0061 Reference 02 PCAC transcript March 9 2016 Supporting & Related Material Background Material 2024-03-20T04:00:00Z 2024 3     2024-03-20T15:37:08Z   0 0 0900006486487b7d
FDA-2023-N-0061-0012 FDA None FDA-2023-N-0061 Reference 09 PCAC briefing May 8-9 2017 Supporting & Related Material Background Material 2024-03-20T04:00:00Z 2024 3     2024-03-20T15:47:41Z   0 0 09000064864886b6
FDA-2023-N-0061-0013 FDA None FDA-2023-N-0061 Reference 10a PCAC briefing Nov 20-21 2017 Supporting & Related Material Background Material 2024-03-20T04:00:00Z 2024 3     2024-03-20T15:48:46Z   0 0 09000064864886a3
FDA-2023-N-0061-0007 FDA None FDA-2023-N-0061 Reference 05 PCAC transcript Nov 21 2017 Supporting & Related Material Background Material 2024-03-20T04:00:00Z 2024 3     2024-03-20T15:40:06Z   0 0 0900006486487b80
FDA-2023-N-0061-0001 FDA None FDA-2023-N-0061 Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act Proposed Rule Notice of Proposed Rulemaking (NPRM) 2024-03-20T04:00:00Z 2024 3 2024-03-20T04:00:00Z 2024-06-19T03:59:59Z 2024-06-20T01:00:32Z 2024-05801 0 0 090000648648745b
FDA-2023-N-0061-0009 FDA None FDA-2023-N-0061 Reference 07a PCAC briefing March 8-9 2016 Supporting & Related Material Background Material 2024-03-20T04:00:00Z 2024 3     2024-03-20T15:44:38Z   0 0 09000064864886b3
FDA-2023-N-0061-0006 FDA None FDA-2023-N-0061 Reference 04 PCAC transcript May 8-9 2017 Supporting & Related Material Background Material 2024-03-20T04:00:00Z 2024 3     2024-03-20T15:39:08Z   0 0 0900006486487b7f
FDA-2023-N-0061-0010 FDA None FDA-2023-N-0061 Reference 07b PCAC briefing March 8-9 2016 errata and addendum Supporting & Related Material Background Material 2024-03-20T04:00:00Z 2024 3     2024-03-20T15:45:43Z   0 0 09000064864886b4
FDA-2023-N-0061-0008 FDA None FDA-2023-N-0061 Reference 06 PCAC briefing June 17-18 2015 Supporting & Related Material Background Material 2024-03-20T04:00:00Z 2024 3     2024-03-20T15:41:55Z   0 0 09000064864886b2
FDA-2023-N-0061-0003 FDA None FDA-2023-N-0061 Reference 01 PCAC transcript June 18 2015 Supporting & Related Material Background Material 2024-03-20T04:00:00Z 2024 3     2024-03-20T15:36:09Z   0 0 0900006486487b7c
FDA-2023-N-0061-0005 FDA None FDA-2023-N-0061 Reference 03 PCAC transcript Nov 3 2016 Supporting & Related Material Background Material 2024-03-20T04:00:00Z 2024 3     2024-03-20T15:38:12Z   0 0 0900006486487b7e
FDA-2023-N-0061-0011 FDA None FDA-2023-N-0061 Reference 08 PCAC briefing Nov 3 2016 Supporting & Related Material Background Material 2024-03-20T04:00:00Z 2024 3     2024-03-20T15:46:39Z   0 0 09000064864886b5
FDA-2023-N-0061-0002 FDA None FDA-2023-N-0061 Reference Summary List for Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under sections 503A and 503B Supporting & Related Material Background Material 2024-03-20T04:00:00Z 2024 3     2024-03-20T15:34:54Z   0 0 0900006486487b7b

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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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