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

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13 rows where docket_id = "FDA-2014-N-1210" and posted_year = 2015 sorted by posted_date descending

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  • 2015 · 13 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2014-N-1210-0003 FDA None FDA-2014-N-1210 Reference 1 - The Practice of Electroconvulsive Therapy - Recommendations for Treatment, Training and Privileging Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:24:31Z   0 0 0900006481dd8bf6
FDA-2014-N-1210-0009 FDA None FDA-2014-N-1210 Reference 7 - Antidepressant Drug Effects and Depression Severity: A Patient-Level Meta-Analysis Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:23:16Z   0 0 0900006481dd8c8e
FDA-2014-N-1210-0011 FDA None FDA-2014-N-1210 Reference 9 - An Examination of Mortality and Other Adverse Events Related to Electroconvulsive Therapy Using a National Adverse Event Report System Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:22:54Z   0 0 0900006481dd8e03
FDA-2014-N-1210-0006 FDA None FDA-2014-N-1210 Reference 4 - Mental Health - A Report of the Surgeon General Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:23:50Z   0 0 0900006481dd8c8b
FDA-2014-N-1210-0004 FDA None FDA-2014-N-1210 Reference 2 - Guidance on the Use of Electroconvulsive Therapy Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:24:16Z   0 0 0900006481dd8bfa
FDA-2014-N-1210-0008 FDA None FDA-2014-N-1210 Reference 6 - Clinical and Cost-Effectiveness of Electroconvulsive Therapy for Depressive Illness, Schizophrenia, Catatonia and Mania-Systematic Reviews and Economic Modelling Studies Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:23:27Z   0 0 0900006481dd8c8d
FDA-2014-N-1210-0007 FDA None FDA-2014-N-1210 Reference 5 - Objective Cognitive Performance Associated with Electroconvulsive Therapy for Depression- A Systematic Review and Meta-Analysis Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:23:38Z   0 0 0900006481dd8c8c
FDA-2014-N-1210-0010 FDA None FDA-2014-N-1210 Reference 8 - Initial Severity and Antidepressant Benefits- A Meta-Analysis of Data Submitted to the Food and Drug Administration Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:23:04Z   0 0 0900006481dd8e02
FDA-2014-N-1210-0002 FDA None FDA-2014-N-1210 List of References for Reclassification of Electroconvulsive Therapy (ECT) Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who are Treatment Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for ECT Devices for Certain Specified Intended Uses Proposed Order Supporting & Related Material List 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:24:43Z   0 0 0900006481dd8bf5
FDA-2014-N-1210-0005 FDA None FDA-2014-N-1210 Reference 3 - Depression in Adults - The Treatment and Management of Depression in Adults Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:24:01Z   0 0 0900006481dd8bfb
FDA-2014-N-1210-0001 FDA None FDA-2014-N-1210 Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy for Certain Specified Intended Uses Proposed Rule Notice of Proposed Rulemaking (NPRM) 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z 2016-03-29T03:59:59Z 2019-01-14T20:50:27Z 2015-32592 0 0 0900006481dd79bf
FDA-2014-N-1210-0012 FDA None FDA-2014-N-1210 Reference 10 - Electroconvulsive Therapy in Lorazepam Non-Responsive Catatonia Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:22:43Z   0 0 0900006481dd8e0a
FDA-2014-N-1210-0013 FDA None FDA-2014-N-1210 Reference 11 - FDA Executive Summary - Prepared for the March 17, 2011 Meeting of the Neurologic Devices Panel Supporting & Related Material Reference (internal unless indicated) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:22:32Z   0 0 0900006481dd8e0b

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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;