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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

17 rows where agency_id = "FDA" and docket_id = "FDA-2008-D-0053" sorted by posted_date descending

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Suggested facets: 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 5

  • 2023 7
  • 2008 3
  • 2025 3
  • 2009 2
  • 2014 2

document_type 2

  • Other 10
  • Notice 7

agency_id 1

  • FDA · 17 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2008-D-0053-0185 FDA None FDA-2008-D-0053 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2025-09-25T04:00:00Z 2025 9     2025-09-25T18:08:26Z 2025-18621 0 0 09000064b8fdca46
FDA-2008-D-0053-0181 FDA None FDA-2008-D-0053 Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Guidance for Industry; Availability; Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request Notice Notice of Availability 2025-01-07T05:00:00Z 2025 1     2025-01-07T20:50:28Z 2024-31539 0 0 09000064868a3430
FDA-2008-D-0053-0183 FDA None FDA-2008-D-0053 Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers; Guidance for Industry Other Guidance 2025-01-07T05:00:00Z 2025 1 2025-01-07T05:00:00Z 2025-02-22T04:59:59Z 2025-06-25T09:00:18Z   1 0 09000064868a5619
FDA-2008-D-0053-0165 FDA None FDA-2008-D-0053 Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Revised Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Extension of Comment Period Notice Extension of Comment Period 2023-11-24T05:00:00Z 2023 11 2023-11-24T05:00:00Z   2023-11-24T17:13:51Z 2023-25969 0 0 09000064862abf15
FDA-2008-D-0053-0162 FDA None FDA-2008-D-0053 Request for Extension from Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO) Other Request for Extension 2023-11-07T05:00:00Z 2023 11 2023-11-07T05:00:00Z   2023-11-07T18:41:49Z   0 0 09000064861d7af7
FDA-2008-D-0053-0161 FDA None FDA-2008-D-0053 Request for Extension from Advanced Medical Technology Association (AdvaMed) Other Request for Extension 2023-11-07T05:00:00Z 2023 11 2023-11-07T05:00:00Z   2023-11-07T18:32:46Z   0 0 09000064861c8732
FDA-2008-D-0053-0163 FDA None FDA-2008-D-0053 Request for Extension from Medical Information Working Group Other Request for Extension 2023-11-07T05:00:00Z 2023 11 2023-11-07T05:00:00Z   2023-11-07T18:55:30Z   0 0 09000064861e7d31
FDA-2008-D-0053-0164 FDA None FDA-2008-D-0053 Request for Extension from Washington Legal Foundation Other Request for Extension 2023-11-07T05:00:00Z 2023 11 2023-11-07T05:00:00Z   2023-11-07T19:05:28Z   0 0 090000648620b5fa
FDA-2008-D-0053-0159 FDA None FDA-2008-D-0053 Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Revised Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request Notice Notice of Availability 2023-10-24T04:00:00Z 2023 10     2023-11-24T17:13:41Z 2023-23372 0 0 090000648612bc1f
FDA-2008-D-0053-0160 FDA None FDA-2008-D-0053 Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Revised Draft Guidance for Industry Other Guidance 2023-10-24T04:00:00Z 2023 10 2023-10-24T04:00:00Z 2024-01-06T04:59:59Z 2025-01-08T02:00:39Z   1 0 090000648612b8dd
FDA-2008-D-0053-0133 FDA None FDA-2008-D-0053 Revised Draft Guidance for Industry on Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices Other Guidance 2014-03-05T05:00:00Z 2014 3 2014-03-05T05:00:00Z   2024-11-12T05:25:20Z   1 0 09000064815fcd13
FDA-2008-D-0053-0132 FDA None FDA-2008-D-0053 Revised Draft Guidance for Industry on Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices; Availability Notice Notice of Availability 2014-03-03T05:00:00Z 2014 3 2014-03-03T05:00:00Z 2014-05-03T03:59:59Z 2014-05-20T20:49:01Z 2014-04560 0 0 09000064815f3466
FDA-2008-D-0053-0127 FDA None FDA-2008-D-0053 Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices - Final Guidance Other Guidance 2009-01-13T05:00:00Z 2009 1 2009-01-13T05:00:00Z 2009-01-14T04:59:59Z 2024-11-12T04:34:09Z   1 0 090000648081d296
FDA-2008-D-0053-0126 FDA None FDA-2008-D-0053 Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices; Availability Notice NAD-Notice of Availability of Data 2009-01-13T05:00:00Z 2009 1 2009-01-13T05:00:00Z   2011-11-30T18:55:39Z E9-00452 0 0 090000648081ccfa
FDA-2008-D-0053-0158 FDA None FDA-2008-D-0053 Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices Guidance for Industry Other Guidance 2008-12-31T05:00:00Z 2008 12 2020-05-13T04:00:00Z   2024-11-06T23:36:21Z   1 0 09000064845ef064
FDA-2008-D-0053-0001 FDA None FDA-2008-D-0053 Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices; Availability Notice NAD-Notice of Availability of Data 2008-02-20T05:00:00Z 2008 2 2008-02-20T05:00:00Z 2008-04-22T03:59:59Z 2008-04-15T05:32:09Z 08-00746 0 0 09000064803b8db8
FDA-2008-D-0053-0002 FDA None FDA-2008-D-0053 Draft Guidance for Industry - [Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices] - Guidance Other GDL-Guidance (Supporting and Related Materials) 2008-02-20T05:00:00Z 2008 2 2008-02-20T05:00:00Z 2008-04-22T03:59:59Z 2011-11-30T18:52:43Z   0 0 09000064803b8f5d

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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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