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withdrawn,object_id
FDA-2007-D-0369-0370,FDA,FDA-2007-D-0369,Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability,Notice,Notice of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,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FDA-2007-D-0369-0364,FDA,FDA-2007-D-0369,"Bioequivalence Recommendations for Progesterone; Draft Guidance for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,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,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FDA-2007-D-0369-0357,FDA,FDA-2007-D-0369,Bioequivalence Recommendations for Lubiprostone; Revised Draft Guidance for Industry; Availability,Notice,Notice of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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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