documents

Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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22 rows where docket_id = "FDA-2016-N-1149" sorted by posted_date descending

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posted_year 5

document_type 2

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-N-1149-0108 FDA None FDA-2016-N-1149 FDA Summary of Premarket Review and Related Authorities for Medical Products _Jan 2025 Other Summary (SUM) 2025-01-06T05:00:00Z 2025 1 2025-01-06T05:00:00Z   2025-01-06T13:37:41Z   0 0 090000648689e39a
FDA-2016-N-1149-0107 FDA None FDA-2016-N-1149 Addendum to Jan 2017 FDA Memo--Additional and Updated Considerations Related to Manufacturer Communications Re Unapproved Uses of Approved or Cleared Medical Products_Jan 2025 Other Additional Information 2025-01-06T05:00:00Z 2025 1 2025-01-06T05:00:00Z   2025-01-06T13:37:28Z   0 0 090000648689e398
FDA-2016-N-1149-0106 FDA None FDA-2016-N-1149 Letter from Ropes & Gray on behalf of Medical Information Working Group (MIWG) to FDA Other Letter(s) 2019-12-03T05:00:00Z 2019 12 2019-12-03T05:00:00Z   2019-12-03T14:16:13Z   0 0 09000064841dde4b
FDA-2016-N-1149-0105 FDA None FDA-2016-N-1149 Kalb et al_IU Final Rule_Response_3-26-18 Other Agency Response 2018-04-09T04:00:00Z 2018 4 2018-04-09T04:00:00Z   2018-04-09T21:13:27Z   0 0 09000064830e95e5
FDA-2016-N-1149-0104 FDA None FDA-2016-N-1149 Petition Interim Response from FDA OP to MIWG Other Letter(s) 2017-08-01T04:00:00Z 2017 8 2017-08-01T04:00:00Z   2017-08-01T14:42:16Z   0 0 0900006482990a65
FDA-2016-N-1149-0087 FDA None FDA-2016-N-1149 Testimony from Anthem Inc. Other Testimony 2017-04-20T04:00:00Z 2017 4 2017-04-20T04:00:00Z   2017-04-20T18:59:26Z   0 0 0900006482560beb
FDA-2016-N-1149-0093 FDA None FDA-2016-N-1149 Testimony from Pfizer Inc. Other Testimony 2017-04-20T04:00:00Z 2017 4 2017-04-20T04:00:00Z   2017-04-20T19:06:43Z   0 0 0900006482561a8d
FDA-2016-N-1149-0075 FDA None FDA-2016-N-1149 Testimony from PharmedOut Other Testimony 2017-04-20T04:00:00Z 2017 4 2017-04-20T04:00:00Z   2017-04-20T16:36:19Z   0 0 090000648255df72
FDA-2016-N-1149-0048 FDA None FDA-2016-N-1149 Petition to Stay and for Reconsideration Other Petition(s) 2017-02-09T05:00:00Z 2017 2 2017-02-09T05:00:00Z   2017-02-09T15:17:05Z   0 0 09000064824b6785
FDA-2016-N-1149-0049 FDA None FDA-2016-N-1149 Acknowledgement Letter From FDA DDM to Sidley Austin LLP and Ropes & Gray LLP Other Acknowledgement Letter/Receipt 2017-02-09T05:00:00Z 2017 2 2017-02-09T05:00:00Z   2017-02-09T16:47:18Z   0 0 09000064824b6e17
FDA-2016-N-1149-0041 FDA None FDA-2016-N-1149 Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Availability of Memorandum; Reopening of the Comment Period Proposed Rule Reopening of Comment Period 2017-01-19T05:00:00Z 2017 1 2017-01-19T05:00:00Z 2017-04-20T03:59:59Z 2017-06-23T01:03:12Z 2017-01013 0 0 090000648248561c
FDA-2016-N-1149-0040 FDA None FDA-2016-N-1149 FDA Memorandum--Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products_Jan 2017 Other Letter(s) 2017-01-18T05:00:00Z 2017 1 2017-01-18T05:00:00Z   2017-01-18T15:22:04Z   0 0 0900006482480cf8
FDA-2016-N-1149-0018 FDA None FDA-2016-N-1149 Testimony from American Association of Neurological Surgeons and Congress of Neurological Surgeons Other Testimony 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T21:10:43Z   0 0 09000064823ba7a1
FDA-2016-N-1149-0013 FDA None FDA-2016-N-1149 Testimony from Advanced Medical Technology Association (AdvaMed) Other Testimony 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T20:15:59Z   0 0 0900006482381f85
FDA-2016-N-1149-0012 FDA None FDA-2016-N-1149 Testimony from Biotechnology Innovation Organization (BIO) Other Testimony 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T20:14:51Z   0 0 090000648238157d
FDA-2016-N-1149-0022 FDA None FDA-2016-N-1149 Testimony from Jerome Lew Other Testimony 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T21:30:38Z   0 0 09000064823f9294
FDA-2016-N-1149-0014 FDA None FDA-2016-N-1149 Testimony from National Women's Health Network Other Testimony 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T20:23:47Z   0 0 0900006482397fc5
FDA-2016-N-1149-0011 FDA None FDA-2016-N-1149 Testimony from Floyd Abrams Other Testimony 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T19:38:38Z   0 0 0900006482364d05
FDA-2016-N-1149-0008 FDA None FDA-2016-N-1149 Transcript of Day 1 on November 9, 2016 Other Transcript(s) 2016-12-13T05:00:00Z 2016 12 2016-12-13T05:00:00Z   2016-12-13T17:12:36Z   0 0 09000064824016af
FDA-2016-N-1149-0009 FDA None FDA-2016-N-1149 Transcript of Day 2 on November 10, 2016 Other Transcript(s) 2016-12-13T05:00:00Z 2016 12 2016-12-13T05:00:00Z   2016-12-13T17:13:48Z   0 0 09000064824016b0
FDA-2016-N-1149-0006 FDA None FDA-2016-N-1149 Testimony from MMpiHer Consulting Other Testimony 2016-10-26T04:00:00Z 2016 10 2016-10-26T04:00:00Z   2016-10-26T16:02:52Z   0 0 090000648234f639
FDA-2016-N-1149-0001 FDA None FDA-2016-N-1149 Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments Proposed Rule Notice of Hearing 2016-09-01T04:00:00Z 2016 9 2016-09-01T04:00:00Z 2017-04-20T03:59:59Z 2017-04-21T01:02:02Z 2016-21062 0 0 09000064821bd14a

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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;