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

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12 rows where agency_id = "FDA" and docket_id = "FDA-2016-P-4587" sorted by posted_date descending

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  • FDA · 12 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-P-4587-0013 FDA None FDA-2016-P-4587 FDA-2016-P-4587 Petition Denial Letter Other Denial of Petition 2017-05-26T04:00:00Z 2017 5 2017-05-26T04:00:00Z   2017-05-26T17:37:37Z   0 0 090000648263f08a
FDA-2016-P-4587-0012 FDA None FDA-2016-P-4587 Supplement from Mallinckrodt Pharmaceuticals Other Supplement (SUP) 2017-05-08T04:00:00Z 2017 5 2017-05-08T04:00:00Z   2017-05-08T21:01:15Z   0 0 090000648256de63
FDA-2016-P-4587-0001 FDA None FDA-2016-P-4587 Citizen Petition from Mallinckrodt Pharmaceuticals Other Citizen Petition 2016-12-28T05:00:00Z 2016 12 2016-12-28T05:00:00Z 2017-06-27T03:59:59Z 2017-05-13T21:06:17Z   0 0 090000648243b8f5
FDA-2016-P-4587-0006 FDA None FDA-2016-P-4587 Exhibit D Praxair Distribution, Inc. v. INO Therapeutics, LLC, IPR2015-00884 (Patent 8,291,904 B2); IPR2015-00888 (Patent 8,776,794 B2); IPR2015-00889 (Patent 8,573,209 B2); IPR2015-00891 (Patent 8,573,210 B2); IPR2015-00893 (Patent 8,776795 B2), Transcript of Proceedings May 16, 2016 re Citizen Petition from Mallinckrodt Pharmaceuticals Supporting & Related Material Background Material 2016-12-28T05:00:00Z 2016 12     2016-12-28T21:51:32Z   0 0 090000648243b8fc
FDA-2016-P-4587-0009 FDA None FDA-2016-P-4587 Exhibit G Praxair Distribution, Inc. vs. Mallinckrodt Hospital Products IP Ltd, IPR 2015-00893 (Patent: 8,776,795 B2), Petitioner’s Reply to Patent Owners Response, Feb. 24, 2016 re Citizen Petition from Mallinckrodt Pharmaceuticals Supporting & Related Material Background Material 2016-12-28T05:00:00Z 2016 12     2016-12-28T21:51:41Z   0 0 090000648243b92e
FDA-2016-P-4587-0007 FDA None FDA-2016-P-4587 Exhibit E Praxair Distribution, Inc. v. INO Therapeutics, LLC d/b/a Ikaria, Inc., Petition for Inter Partes Review of U.S. Patent No. 8,776,795, March 16, 2015 re Citizen Petition from Mallinckrodt Pharmaceuticals Supporting & Related Material Background Material 2016-12-28T05:00:00Z 2016 12     2016-12-28T21:51:35Z   0 0 090000648243b8fd
FDA-2016-P-4587-0010 FDA None FDA-2016-P-4587 Exhibit H Tissue Debate Raises Fairness, Transparency Questions for Combo Products, The Gray Sheet (4/29/2002) re Citizen Petition from Mallinckrodt Pharmaceuticals Supporting & Related Material Background Material 2016-12-28T05:00:00Z 2016 12     2016-12-28T21:51:44Z   0 0 090000648243b92f
FDA-2016-P-4587-0002 FDA None FDA-2016-P-4587 Acknowledgement Letter from FDA DDM to Mallinckrodt Pharmaceuticals Other Acknowledgement Letter/Receipt 2016-12-28T05:00:00Z 2016 12 2016-12-28T05:00:00Z   2016-12-28T21:51:19Z   0 0 090000648243b8f7
FDA-2016-P-4587-0005 FDA None FDA-2016-P-4587 Exhibit C Import Alert # 89-04, Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System Requirements (March 16, 2016) (Excerpt) re Citizen Petition from Mallinckrodt Pharmaceuticals Supporting & Related Material Background Material 2016-12-28T05:00:00Z 2016 12     2016-12-28T21:51:29Z   0 0 090000648243b8fb
FDA-2016-P-4587-0003 FDA None FDA-2016-P-4587 Exhibit A Transcript of Proceedings, Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee (Nov. 22, 1996) re Citizen Petition from Mallinckrodt Pharmaceuticals Supporting & Related Material Background Material 2016-12-28T05:00:00Z 2016 12     2016-12-28T21:51:22Z   0 0 090000648243b8f9
FDA-2016-P-4587-0004 FDA None FDA-2016-P-4587 Exhibit B Life-threatening effects of discontinuing inhaled nitric oxide in severe respiratory failure. Am. J. Respir. Crit. Care Med. 1996:153;1985-87 re Citizen Petition from Mallinckrodt Pharmaceuticals Supporting & Related Material Background Material 2016-12-28T05:00:00Z 2016 12     2016-12-28T21:51:25Z   0 0 090000648243b8fa
FDA-2016-P-4587-0008 FDA None FDA-2016-P-4587 Exhibit F Declaration of Robert T. Stone, Ph.D., IPR (unassigned, Patent: 8,291,904), March 13, 2015 re Citizen Petition from Mallinckrodt Pharmaceuticals Supporting & Related Material Background Material 2016-12-28T05:00:00Z 2016 12     2016-12-28T21:51:38Z   0 0 090000648243b92d

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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;