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Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

30 rows where docket_id = "FDA-2015-D-2537" 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 3

  • 2015 16
  • 2016 11
  • 2017 3

document_type 3

  • Other 23
  • Notice 5
  • Supporting & Related Material 2

agency_id 1

  • FDA 30
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-D-2537-0141 FDA None FDA-2015-D-2537 PCPC Additional Comments Other Background Material 2017-12-06T05:00:00Z 2017 12 2017-12-06T05:00:00Z   2017-12-06T13:29:24Z   0 0 0900006482ce9273
FDA-2015-D-2537-0140 FDA None FDA-2015-D-2537 ISPE Additional Comments Other Letter(s) 2017-11-03T04:00:00Z 2017 11 2017-11-03T04:00:00Z   2017-11-03T16:58:11Z   0 0 0900006482c3fce8
FDA-2015-D-2537-0109 FDA None FDA-2015-D-2537 Submission of Quality Metrics Data; Revised Draft Guidance for Industry; Extension of Comment Period Notice Extension of Comment Period 2017-01-09T05:00:00Z 2017 1 2017-01-09T05:00:00Z 2017-03-28T03:59:59Z 2017-03-28T13:02:48Z 2017-00094 0 0 09000064824529dd
FDA-2015-D-2537-0108 FDA None FDA-2015-D-2537 Request to Extend Comment Period from CGA and GAWDA Other Request for Extension 2016-12-28T05:00:00Z 2016 12 2016-12-28T05:00:00Z   2016-12-28T16:49:10Z   0 0 090000648243b643
FDA-2015-D-2537-0107 FDA None FDA-2015-D-2537 Request to Extend Comment Period from Cook Group, Inc. Other Request for Extension 2016-12-28T05:00:00Z 2016 12 2016-12-28T05:00:00Z   2016-12-28T16:46:19Z   0 0 090000648243b1a1
FDA-2015-D-2537-0105 FDA None FDA-2015-D-2537 Request to Extend Comment Period from Pharma & Biopharma Outsourcing Association Other Electronic Regulation from Form 2016-12-22T05:00:00Z 2016 12 2016-12-22T05:00:00Z   2016-12-22T20:04:48Z   0 0 09000064824317b3
FDA-2015-D-2537-0106 FDA None FDA-2015-D-2537 Request to Extend Comment Period from Catalent Pharma Solutions Other Request for Extension 2016-12-22T05:00:00Z 2016 12 2016-12-22T05:00:00Z   2016-12-28T16:46:10Z   0 0 09000064824321de
FDA-2015-D-2537-0104 FDA None FDA-2015-D-2537 Request to Extend Comment Period from Compressed Gas Association and the Gases and Welding Distributors Association Other Request for Extension 2016-12-22T05:00:00Z 2016 12 2016-12-22T05:00:00Z   2016-12-22T20:01:13Z   0 0 090000648242e6a6
FDA-2015-D-2537-0103 FDA None FDA-2015-D-2537 Request for Extension from International Society for Pharmaceutical Engineering (ISPE) Other Request for Extension 2016-12-20T05:00:00Z 2016 12 2016-12-20T05:00:00Z   2016-12-20T19:46:47Z   0 0 090000648242879c
FDA-2015-D-2537-0102 FDA None FDA-2015-D-2537 Request for Extension from Teva Pharmaceutical Other Request for Extension 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T17:21:45Z   0 0 090000648241b220
FDA-2015-D-2537-0101 FDA None FDA-2015-D-2537 Request for Extension from Biotechnology Innovation Organization (BIO) et al Other Electronic Regulation from Form 2016-12-13T05:00:00Z 2016 12 2016-12-13T05:00:00Z   2016-12-13T20:04:38Z   0 0 0900006482401dbb
FDA-2015-D-2537-0100 FDA None FDA-2015-D-2537 Request for Extension from Parenteral Drug Association Other Request for Extension 2016-12-13T05:00:00Z 2016 12 2016-12-13T05:00:00Z   2016-12-13T19:59:41Z   0 0 09000064823f9bda
FDA-2015-D-2537-0097 FDA None FDA-2015-D-2537 Submission of Quality Metrics Data; Draft Guidance for Industry; Availability; Request for Comments Notice Notice of Availability 2016-11-25T05:00:00Z 2016 11 2016-11-25T05:00:00Z 2017-03-28T03:59:59Z 2017-03-29T01:00:56Z 2016-28332 0 0 09000064823bef38
FDA-2015-D-2537-0098 FDA None FDA-2015-D-2537 Submission of Quality Metrics Data Guidance for Industry Other Guidance 2016-11-25T05:00:00Z 2016 11 2016-11-25T05:00:00Z   2024-11-12T06:17:15Z   1 0 09000064823bf567
FDA-2015-D-2537-0040 FDA None FDA-2015-D-2537 Report from ISPE - Quality Metrics Initiative Wave 1 Other Report 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2015-11-18T15:19:20Z   0 0 0900006481d54fe6
FDA-2015-D-2537-0033 FDA None FDA-2015-D-2537 Presentation by Consumer Healthcare Products Association (CHPA) regarding the Quality Metrics Public Meeting Other Presentation 2015-10-22T04:00:00Z 2015 10 2015-10-22T04:00:00Z   2015-10-22T20:50:10Z   0 0 0900006481ce316e
FDA-2015-D-2537-0039 FDA None FDA-2015-D-2537 Presentation by R. M. Johnson, Parenteral Drug Association (PDA) regarding the Quality Metrics Public Meeting Other Presentation 2015-10-22T04:00:00Z 2015 10 2015-10-22T04:00:00Z   2015-10-22T21:11:49Z   0 0 0900006481ce3223
FDA-2015-D-2537-0034 FDA None FDA-2015-D-2537 Presentation by Ashley Boam, FDA/CDER regarding the Quality Metrics Public Meeting Other Presentation 2015-10-22T04:00:00Z 2015 10 2015-10-22T04:00:00Z   2015-10-22T20:48:50Z   0 0 0900006481ce3173
FDA-2015-D-2537-0035 FDA None FDA-2015-D-2537 Presentation by Ron Fitzmartin, Ph.D., FDA/CDER regarding the Quality Metrics Public Meeting Other Presentation 2015-10-22T04:00:00Z 2015 10 2015-10-22T04:00:00Z   2015-10-22T20:54:14Z   0 0 0900006481ce3175
FDA-2015-D-2537-0036 FDA None FDA-2015-D-2537 Presentation by David Gaugh, R.Ph., GPhA regarding the Quality Metrics Public Meeting Other Presentation 2015-10-22T04:00:00Z 2015 10 2015-10-22T04:00:00Z   2015-10-22T20:58:15Z   0 0 0900006481ce3220
FDA-2015-D-2537-0031 FDA None FDA-2015-D-2537 Presentation by Alan Nicholls, Bulk Pharmaceuticals Task Force (BPTF) regarding the Quality Metrics Public Meeting Other Presentation 2015-10-22T04:00:00Z 2015 10 2015-10-22T04:00:00Z   2015-10-22T20:50:29Z   0 0 0900006481ce2c0e
FDA-2015-D-2537-0037 FDA None FDA-2015-D-2537 Presentation by Priscilla Zawislak, International Pharmaceutical Excipients Council of the Americas (IPEC) regarding the Quality Metrics Public Meeting Other Presentation 2015-10-22T04:00:00Z 2015 10 2015-10-22T04:00:00Z   2015-10-22T21:04:57Z   0 0 0900006481ce3221
FDA-2015-D-2537-0038 FDA None FDA-2015-D-2537 Presentation by ISPE regarding the Quality Metrics Public Meeting Other Presentation 2015-10-22T04:00:00Z 2015 10 2015-10-22T04:00:00Z   2015-10-22T21:08:02Z   0 0 0900006481ce3222
FDA-2015-D-2537-0022 FDA None FDA-2015-D-2537 Attachment 1: Quality Metrics re: Comment from ECA Foundation Supporting & Related Material Background Material 2015-09-22T04:00:00Z 2015 9     2015-09-22T16:08:56Z   0 0 0900006481c8bcc4
FDA-2015-D-2537-0017 FDA None FDA-2015-D-2537 Attachment 1: Quality Metrics Survey re Comment from ECA Foundation Supporting & Related Material Background Material 2015-09-22T04:00:00Z 2015 9     2015-09-22T15:38:21Z   0 0 0900006481c8bcbf
FDA-2015-D-2537-0015 FDA None FDA-2015-D-2537 Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Extension of Comment Period Notice Extension of Comment Period 2015-08-26T04:00:00Z 2015 8 2015-08-26T04:00:00Z 2015-11-28T04:59:59Z 2015-11-28T22:00:32Z 2015-21149 0 0 0900006481c3a8b4
FDA-2015-D-2537-0010 FDA None FDA-2015-D-2537 Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Correction Notice Correction 2015-08-07T04:00:00Z 2015 8 2015-08-07T04:00:00Z   2015-08-07T13:20:23Z 2015-19487 0 0 0900006481bca608
FDA-2015-D-2537-0009 FDA None FDA-2015-D-2537 Request for Extension from Generic Pharmaceutical Association (GPhA) Other Request for Extension 2015-08-04T04:00:00Z 2015 8 2015-07-28T04:00:00Z 2015-09-29T03:59:59Z 2015-10-22T19:19:27Z   0 0 0900006481bbb288
FDA-2015-D-2537-0002 FDA None FDA-2015-D-2537 Request for Quality Metrics Guidance for Industry Draft Guidance Other Guidance 2015-07-28T04:00:00Z 2015 7 2015-07-28T04:00:00Z   2024-11-11T21:07:59Z   1 0 0900006481baae35
FDA-2015-D-2537-0001 FDA None FDA-2015-D-2537 Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments Notice Notice of Availability 2015-07-28T04:00:00Z 2015 7 2015-07-28T04:00:00Z 2015-09-29T03:59:59Z 2015-09-29T01:30:54Z 2015-18448 0 0 0900006481baa6bd

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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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