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30 rows where docket_id = "FDA-2015-D-2537" sorted by posted_date descending
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document_type 3
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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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| FDA-2015-D-2537-0109 | FDA | None FDA-2015-D-2537 | Submission of Quality Metrics Data; Revised Draft Guidance for Industry; Extension of Comment Period | Notice | Extension of Comment Period | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T05:00:00Z |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;