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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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document_type 3

  • Supporting & Related Material 27
  • Notice 8
  • Other 1

posted_year 1

  • 2015 · 36 ✖

agency_id 1

  • FDA 36
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2007-D-0369-0370 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z 2016-03-01T04:59:59Z 2016-02-29T22:00:18Z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FDA-2007-D-0369-0364 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for Progesterone; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-11-02T05:00:00Z 2015 11 2015-11-02T05:00:00Z 2016-01-05T04:59:59Z 2024-11-07T23:29:55Z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FDA-2007-D-0369-0357 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for Lubiprostone; Revised Draft Guidance for Industry; Availability Notice Notice of Availability 2015-07-20T04:00:00Z 2015 7 2015-07-20T04:00:00Z 2015-09-19T03:59:59Z 2015-07-20T14:50:30Z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;
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