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36 rows where docket_id = "FDA-2007-D-0369" and posted_year = 2015 sorted by posted_date descending
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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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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| FDA-2007-D-0369-0370 | FDA | None FDA-2007-D-0369 | Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2015-12-29T05:00:00Z | 2015 | 12 | 2015-12-29T05:00:00Z | 2016-03-01T04:59:59Z | 2016-02-29T22:00:18Z | 2015-32723 | 0 | 0 | 0900006481dd74ac |
| FDA-2007-D-0369-0365 | FDA | None FDA-2007-D-0369 | Request to Extend the Comment Period from Raptor Pharmaceutical Corp | Other | Request for Extension | 2015-11-16T05:00:00Z | 2015 | 11 | 2015-11-16T05:00:00Z | 2015-11-16T17:53:57Z | 0 | 0 | 0900006481d49c93 | ||
| FDA-2007-D-0369-0364 | FDA | None FDA-2007-D-0369 | Bioequivalence Recommendations for Progesterone; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2015-11-02T05:00:00Z | 2015 | 11 | 2015-11-02T05:00:00Z | 2016-01-05T04:59:59Z | 2024-11-07T23:29:55Z | 2015-27816 | 1 | 0 | 0900006481d02d3e |
| FDA-2007-D-0369-0361 | FDA | None FDA-2007-D-0369 | Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability | Notice | Notice of Availability | 2015-09-21T04:00:00Z | 2015 | 9 | 2015-09-21T04:00:00Z | 2015-11-21T04:59:59Z | 2024-11-12T05:46:52Z | 2015-23571 | 1 | 0 | 0900006481c87c63 |
| FDA-2007-D-0369-0358 | FDA | None FDA-2007-D-0369 | Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability; Correction | Notice | Correction | 2015-07-23T04:00:00Z | 2015 | 7 | 2015-07-23T04:00:00Z | 2015-07-23T17:17:42Z | 2015-18024 | 0 | 0 | 0900006481b9b036 | |
| FDA-2007-D-0369-0357 | FDA | None FDA-2007-D-0369 | Bioequivalence Recommendations for Lubiprostone; Revised Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2015-07-20T04:00:00Z | 2015 | 7 | 2015-07-20T04:00:00Z | 2015-09-19T03:59:59Z | 2015-07-20T14:50:30Z | 2015-17726 | 0 | 0 | 0900006481b92321 |
| FDA-2007-D-0369-0356 | FDA | None FDA-2007-D-0369 | Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability | Notice | Notice of Availability | 2015-06-30T04:00:00Z | 2015 | 6 | 2015-06-30T04:00:00Z | 2015-09-01T03:59:59Z | 2015-09-18T01:31:22Z | 2015-16013 | 0 | 0 | 0900006481b5dd9f |
| FDA-2007-D-0369-0355 | FDA | None FDA-2007-D-0369 | Attachment A Suggested Guidance Redlined re Comment from Celgene Corporation and Abraxis BioScience LLC | Supporting & Related Material | Background Material | 2015-06-12T04:00:00Z | 2015 | 6 | 2015-06-12T13:30:37Z | 0 | 0 | 0900006481b30d1a | |||
| FDA-2007-D-0369-0354 | FDA | None FDA-2007-D-0369 | Attachment A Suggested Guidance Clean Draft Guidance on Paclitaxel re Comment from Celgene Corporation and Abraxis BioScience LLC | Supporting & Related Material | Background Material | 2015-06-12T04:00:00Z | 2015 | 6 | 2015-06-12T13:28:54Z | 0 | 0 | 0900006481b30824 | |||
| FDA-2007-D-0369-0352 | FDA | None FDA-2007-D-0369 | Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2015-05-27T04:00:00Z | 2015 | 5 | 2015-05-27T04:00:00Z | 2015-07-28T03:59:59Z | 2024-11-07T23:24:04Z | 2015-12847 | 1 | 0 | 0900006481b04fd7 |
| FDA-2007-D-0369-0342 | FDA | None FDA-2007-D-0369 | Approved Drug Products with Therapeutic Equivalence Evaluations re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T15:50:33Z | 0 | 0 | 0900006481ade148 | |||
| FDA-2007-D-0369-0337 | FDA | None FDA-2007-D-0369 | GDUFA Public Hearing Transcript (May 16, 2014) re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Transcript | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T16:08:13Z | 0 | 0 | 0900006481ade139 | |||
| FDA-2007-D-0369-0340 | FDA | None FDA-2007-D-0369 | Citizen Petition from Luitpold Pharmaceuticals Inc re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T15:35:05Z | 0 | 0 | 0900006481ade143 | |||
| FDA-2007-D-0369-0329 | FDA | None FDA-2007-D-0369 | Prescribing Information Velphoro PI (9-2014) re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T14:14:27Z | 0 | 0 | 0900006481ade122 | |||
| FDA-2007-D-0369-0338 | FDA | None FDA-2007-D-0369 | H.R. 1576 114th Congress 1st Session re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T15:12:30Z | 0 | 0 | 0900006481ade13a | |||
| FDA-2007-D-0369-0350 | FDA | None FDA-2007-D-0369 | Response from FDA CDER to Bristol-Myers Squibb Co Denial of Petition re comment from Vifor Pharma, Ltd. | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T16:14:24Z | 0 | 0 | 0900006481ade150 | |||
| FDA-2007-D-0369-0332 | FDA | None FDA-2007-D-0369 | FDA Biosimilar Biological Products Webinar (Feb 15, 2012) re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T14:41:53Z | 0 | 0 | 0900006481ade12f | |||
| FDA-2007-D-0369-0334 | FDA | None FDA-2007-D-0369 | Letters to the Editor GIE Journal re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T14:56:07Z | 0 | 0 | 0900006481ade135 | |||
| FDA-2007-D-0369-0336 | FDA | None FDA-2007-D-0369 | GDUFA Regulatory Science Update (Feb 9, 2015) re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T15:06:07Z | 0 | 0 | 0900006481ade138 | |||
| FDA-2007-D-0369-0330 | FDA | None FDA-2007-D-0369 | NIH Public Access Hruska et al re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T14:29:33Z | 0 | 0 | 0900006481ade129 | |||
| FDA-2007-D-0369-0348 | FDA | None FDA-2007-D-0369 | Levothyroxine Sodium Products Joint Public Meeting Transcript May 2005 re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Transcript | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T16:06:44Z | 0 | 0 | 0900006481ade14e | |||
| FDA-2007-D-0369-0341 | FDA | None FDA-2007-D-0369 | Prescribing Information Auryxia re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T15:47:51Z | 0 | 0 | 0900006481ade147 | |||
| FDA-2007-D-0369-0347 | FDA | None FDA-2007-D-0369 | Draft Guidance on Lanthanum Carbonate (Nov 2013) re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T16:04:18Z | 0 | 0 | 0900006481ade14d | |||
| FDA-2007-D-0369-0331 | FDA | None FDA-2007-D-0369 | FDA Overview of Biological Products re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T14:39:38Z | 0 | 0 | 0900006481ade12e | |||
| FDA-2007-D-0369-0333 | FDA | None FDA-2007-D-0369 | Draft Guidance on Iron Sucrose (Nov 2013) re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T14:44:23Z | 0 | 0 | 0900006481ade130 | |||
| FDA-2007-D-0369-0339 | FDA | None FDA-2007-D-0369 | Cited Article Geisser and Burckhardt re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T15:15:26Z | 0 | 0 | 0900006481ade13b | |||
| FDA-2007-D-0369-0343 | FDA | None FDA-2007-D-0369 | Draft Guidance on Cholestyramine (Mar 2012) re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T15:52:20Z | 0 | 0 | 0900006481ade149 | |||
| FDA-2007-D-0369-0344 | FDA | None FDA-2007-D-0369 | Draft Guidance on Colesevelam hydrochloride (Powder June 2013) re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T15:55:14Z | 0 | 0 | 0900006481ade14a | |||
| FDA-2007-D-0369-0335 | FDA | None FDA-2007-D-0369 | Draft Guidance BE Studies with PK Endpoings for Drugs Submitted under an ANDA (Dec 2013) re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T14:58:53Z | 0 | 0 | 0900006481ade136 | |||
| FDA-2007-D-0369-0345 | FDA | None FDA-2007-D-0369 | Draft Guidance on Colesevelam Hydrochloride (Tablet Nov 2013) re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T16:00:21Z | 0 | 0 | 0900006481ade14b | |||
| FDA-2007-D-0369-0349 | FDA | None FDA-2007-D-0369 | Response from FDA / CDER to Shire Development Partial Approval and Denial of Petition re comment from Vifor Pharma, Ltd. | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T16:12:11Z | 0 | 0 | 0900006481ade14f | |||
| FDA-2007-D-0369-0351 | FDA | None FDA-2007-D-0369 | Draft Guidance on Sevelamer Hydrochloride re comment from Vifor Pharma, Ltd. | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T16:18:59Z | 0 | 0 | 0900006481ade152 | |||
| FDA-2007-D-0369-0346 | FDA | None FDA-2007-D-0369 | Draft Guidance on Colestipol Hydrochloride re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T16:01:58Z | 0 | 0 | 0900006481ade14c | |||
| FDA-2007-D-0369-0327 | FDA | None FDA-2007-D-0369 | Index of Exhibits re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T13:54:44Z | 0 | 0 | 0900006481addb3f | |||
| FDA-2007-D-0369-0328 | FDA | None FDA-2007-D-0369 | Federal Register Notice Draft Guidance for Industry on Bioequivalence Recommendations for Sucroferric Oxyhydroxide 80 Fed. Reg. 12,503 re Comment from Vifor Pharma, Ltd | Supporting & Related Material | Background Material | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T14:12:31Z | 0 | 0 | 0900006481addb43 | |||
| FDA-2007-D-0369-0314 | FDA | None FDA-2007-D-0369 | Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability | Notice | Notice of Availability | 2015-03-09T04:00:00Z | 2015 | 3 | 2015-03-09T04:00:00Z | 2015-05-09T03:59:59Z | 2017-04-21T01:02:06Z | 2015-05347 | 0 | 0 | 0900006481a34223 |
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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;