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withdrawn,object_id FDA-2011-D-0872-0002,FDA,FDA-2011-D-0872,Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies,Other,Guidance,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,2011-03-30T03:59:59Z,2011-12-30T13:38:31Z,,0,0,0900006480f8b808 FDA-2011-D-0868-0002,FDA,FDA-2011-D-0868,Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,Other,Citizen Petition,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,,2024-11-07T23:55:25Z,,1,0,0900006480f8b82a FDA-1991-P-0165-0002,FDA,FDA-1991-P-0165,"FDA/CDRH Hydergine Memo, dated 12/28/2011 to Division of Dockets Management",Other,Memo,2011-12-29T05:00:00Z,2011,12,2011-12-29T05:00:00Z,,2024-11-12T04:15:45Z,,1,0,0900006480f8ae25 FDA-1995-P-0246-0002,FDA,FDA-1995-P-0246,Memorandum from FDA CDER to FDA DDM,Other,Memorandum,2011-12-29T05:00:00Z,2011,12,2011-12-29T05:00:00Z,,2025-09-15T23:09:53Z,,1,0,0900006480f8ae55 EPA-HQ-OPP-2010-0466-0009,EPA,EPA-HQ-OPP-2010-0466,Public Participation: Novaluron,Other,Public Participation,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,2012-01-28T04:59:59Z,2011-12-28T21:53:42Z,,0,0,0900006480f8a398 FDA-1997-S-0006-1140,FDA,FDA-1997-S-0006,"Indiana Botanic Gardens, Inc., LET1140 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T19:17:21Z,,0,0,0900006480f85d4d FDA-1997-S-0006-1137,FDA,FDA-1997-S-0006,New Century Company LET1137 Response From FDA/CFSAN - Courtesy Letter,Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T18:47:38Z,,0,0,0900006480f85d47 FDA-2011-P-0913-0002,FDA,FDA-2011-P-0913,"Acknowledgement Letter to KVK-Tech, Inc.",Other,Acknowledgement Letter/Receipt,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T23:00:45Z,,0,0,0900006480f847f9 FDA-2011-P-0923-0001,FDA,FDA-2011-P-0923,Public Citizen Health Research Group - Citizen Petition,Other,Citizen Petition,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2012-08-08T18:44:33Z,,0,0,0900006480f88963 FDA-1997-S-0006-1141,FDA,FDA-1997-S-0006,Cobalis Corporation LET1141 Response From FDA/CFSAN - Courtesy Letter,Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T19:23:16Z,,0,0,0900006480f85d4f FDA-1997-S-0006-1136,FDA,FDA-1997-S-0006,Country Life LET1136 Response From FDA/CFSAN - Courtesy Letter,Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T17:27:48Z,,0,0,0900006480f85d45 FDA-1997-S-0006-1143,FDA,FDA-1997-S-0006,"New Chapter, Inc., LET1143 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T19:50:27Z,,0,0,0900006480f85d53 FDA-2011-D-0652-0002,FDA,FDA-2011-D-0652,Draft Guidance for Industry and Food and Drug Administration Staff The 510(k) Program Evaluating Substantial Equivalence in Premarket Notifications [510(k)],Other,Guidance,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,2012-04-27T03:59:59Z,2014-09-27T01:07:24Z,,0,0,0900006480f8a513 FDA-2011-D-0893-0002,FDA,FDA-2011-D-0893,Draft Guidances for Industry and Staff Center for Devices and Radiological Health Appeals Processes,Other,Guidance,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,2012-04-27T03:59:59Z,2011-12-28T16:23:06Z,,0,0,0900006480f8a53c FDA-2011-P-0923-0002,FDA,FDA-2011-P-0923,Acknowledgement Letter to Public Citizen Health Research Group,Other,Acknowledgement Letter/Receipt,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T22:30:59Z,,0,0,0900006480f88965 FDA-2010-D-0313-0018,FDA,FDA-2010-D-0313,"Guidance for Industry; Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation",Other,Guidance,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2024-11-07T01:40:00Z,,1,0,0900006480f89bae FDA-2011-P-0913-0001,FDA,FDA-2011-P-0913,"KVK-Tech, Inc. - Citizen Petition",Other,Citizen Petition,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2013-01-31T14:54:18Z,,0,0,0900006480f847f5 FDA-1997-S-0006-1139,FDA,FDA-1997-S-0006,"Nuvilex, Inc., LET1139 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T19:10:07Z,,0,0,0900006480f85d4b FDA-1997-S-0006-1142,FDA,FDA-1997-S-0006,"NatureGift (USA), Inc., LET1142 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T19:40:19Z,,0,0,0900006480f85d51 FDA-1997-S-0006-1132,FDA,FDA-1997-S-0006,"Nutrition21, LET1132 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T16:34:57Z,,0,0,0900006480f85d3d FDA-1997-S-0006-1138,FDA,FDA-1997-S-0006,Better Health Beverage (Foley & Lardner LLP.) LET1138 Response From FDA/CFSAN - Courtesy Letter,Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T18:57:22Z,,0,0,0900006480f85d49 FDA-2011-P-0734-0003,FDA,FDA-2011-P-0734,FDA/CDER Response to Richard J. Miller - Petition Denial,Other,Denial of Petition,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T23:15:07Z,,0,0,0900006480f8a924 FDA-1997-S-0006-1134,FDA,FDA-1997-S-0006,Source Naturals LET1134 Response From FDA/CFSAN - Courtesy Letter,Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T17:14:06Z,,0,0,0900006480f85d41 FDA-1997-S-0006-1133,FDA,FDA-1997-S-0006,New Century Company LET1133 Response From FDA/CFSAN - Courtesy Letter,Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T17:07:01Z,,0,0,0900006480f85d3f FDA-1997-S-0006-1135,FDA,FDA-1997-S-0006,Planetary Ayurvedics LET1135 Response From FDA/CFSAN - Courtesy Letter,Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T17:20:39Z,,0,0,0900006480f85d43 FDA-2011-P-0852-0001,FDA,FDA-2011-P-0852,Dr. S. Albert Edwards - Citizen Petition,Other,Citizen Petition,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,,2016-05-17T10:48:51Z,,0,0,0900006480f74b19 FDA-2011-P-0852-0002,FDA,FDA-2011-P-0852,Acknowledgement Letter to Dr. S. Albert Edwards,Other,Acknowledgement Letter/Receipt,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,,2011-12-27T19:31:22Z,,0,0,0900006480f74b64 FDA-1978-N-0021-0042,FDA,FDA-1978-N-0021,FDA/CDER Maalox Total Relief Memo Meeting minutes and Quarterly Reports 12 9 11,Other,Report,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,,2011-12-27T13:50:45Z,,0,0,0900006480f899cc EPA-HQ-OPP-2009-0364-0028,EPA,EPA-HQ-OPP-2009-0364,Revised Memo: Public Participation new active ingredient Fluopyram,Other,Public Participation,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,2012-01-24T04:59:59Z,2011-12-28T20:26:08Z,,0,0,0900006480f88d9f FDA-2011-M-0866-0001,FDA,FDA-2011-M-0866,Premarket Approval of Dako Denmark A/S HER2 CISH pharmDx™ Kit,Other,Approval,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2011-12-23T19:22:55Z,,0,0,0900006480f80833 FDA-2011-V-0895-0002,FDA,FDA-2011-V-0895,Acknowledgement Letter to Laser Sky Designs,Other,Acknowledgement Letter/Receipt,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2011-12-23T19:10:11Z,,0,0,0900006480f805cf FDA-2011-A-0346-0003,FDA,FDA-2011-A-0346,"Acknowledgement Letter to Radiation Safety Committee, University of California, Irvine Medical Center",Other,Acknowledgement Letter/Receipt,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2014-01-20T20:06:38Z,,0,0,0900006480c6cd64 FDA-2010-P-0222-0003,FDA,FDA-2010-P-0222,"Alaunus Pharmaceutical, LLC - Withdrawal",Other,Withdrawal,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2011-12-23T18:47:04Z,,0,0,0900006480f81d09 FDA-2010-P-0460-0003,FDA,FDA-2010-P-0460,"Alaunus Pharmaceutical, LLC - Amendment",Other,Amendment,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2011-12-23T17:54:48Z,,0,0,0900006480f82074 FDA-2011-A-0346-0002,FDA,FDA-2011-A-0346,"Radiation Safety Committee, University of California, Irvine Medical Center - Advisory Opinion",Other,Advisory Opinion Petition,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2014-01-20T20:20:54Z,,0,0,0900006480c6cd63 FDA-2011-V-0894-0002,FDA,FDA-2011-V-0894,Acknowledgement Letter to Hypnotix Entertainment,Other,Acknowledgement Letter/Receipt,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2011-12-23T18:59:17Z,,0,0,0900006480f805c8 FDA-2011-V-0894-0001,FDA,FDA-2011-V-0894,Hypnotix Entertainment - Application for Variance,Other,Application for Variance (VAR),2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2011-12-23T18:59:17Z,,0,0,0900006480f80586 FDA-2011-V-0895-0001,FDA,FDA-2011-V-0895,Laser Sky Designs - Application for Variance,Other,Application for Variance (VAR),2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2011-12-23T19:10:10Z,,0,0,0900006480f805cc EPA-HQ-OPP-2009-0364-0007,EPA,EPA-HQ-OPP-2009-0364,Public Participation for New Active Ingredient Fluopyram,Other,Public Participation,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,2012-01-24T04:59:59Z,2011-12-28T20:24:44Z,,0,0,0900006480f882b7 EPA-HQ-OPP-2010-0806-0003,EPA,EPA-HQ-OPP-2010-0806,Public Participation: New active ingredient Pasteuria nishizawae,Other,Public Participation,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,2012-01-22T04:59:59Z,2011-12-22T15:55:26Z,,0,0,0900006480f87857 EPA-HQ-OPP-2010-0043-0002,EPA,EPA-HQ-OPP-2010-0043,"Public Participation for Pesticide Active Ingredient Flazasulfron for Food Use , Uses on Christmas Trees, and Industrial Management Areas.",Other,Public Participation,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,2012-01-21T04:59:59Z,2012-02-09T16:59:21Z,,0,0,0900006480f88103 EPA-HQ-OPP-2010-0106-0007,EPA,EPA-HQ-OPP-2010-0106,Public Participation for New Active Ingredient Aureobasidium pullulans strain DSM 14941,Other,Public Participation,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,2012-01-23T04:59:59Z,2024-11-08T03:46:29Z,,1,0,0900006480f87bde EPA-HQ-OPP-2010-0100-0003,EPA,EPA-HQ-OPP-2010-0100,Public Participation for New Active Ingredient Aureobasidium pullulans strain DSM 14940,Other,Public Participation,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,2012-01-23T04:59:59Z,2011-12-22T14:43:31Z,,0,0,0900006480f87be0 FDA-2011-A-0346-0001,FDA,FDA-2011-A-0346,"FDA/CDER Response to Radiation Safety Committee, University of California, Irvine Medical Center - Letter",Other,Letter(s),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-23T18:35:16Z,,0,0,0900006480f854fd FDA-2001-P-0123-0186,FDA,FDA-2001-P-0123,FDA-CDER/ to Center for Reproductive Rights - Petition Denial,Other,Denial of Petition,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T18:07:45Z,,0,0,0900006480f8816b FDA-2007-N-0475-0035,FDA,FDA-2007-N-0475,"FDA/OC to Parties, from the Office of the Commissioner, December 15, 2011 - Letter",Other,Letter(s),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T18:45:27Z,,0,0,0900006480f88195 FDA-2011-P-0552-0003,FDA,FDA-2011-P-0552,Robert Wagner to FDA's Division of Dockets Management - Letter,Other,Letter(s),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T21:26:14Z,,0,0,0900006480f8158b FDA-2011-V-0896-0002,FDA,FDA-2011-V-0896,"Acknowledgement Letter to Patete Taylor Films, Inc. dba Boulevard Films",Other,Acknowledgement Letter/Receipt,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T17:21:12Z,,0,0,0900006480f805fe FDA-2011-V-0892-0001,FDA,FDA-2011-V-0892,The Boys DJ - Application for Variance,Other,Application for Variance (VAR),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T16:45:22Z,,0,0,0900006480f80581 FDA-2011-M-0865-0001,FDA,FDA-2011-M-0865,Premarket Approval of PROMUS® Element™ Plus Everolimus-Eluting Platinum Coronary Stent System (Monorail™ and Over-The-Wire),Other,Approval,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T20:58:20Z,,0,0,0900006480f807f8 FDA-2011-V-0897-0002,FDA,FDA-2011-V-0897,Acknowledgement Letter to NLFX Professional,Other,Acknowledgement Letter/Receipt,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T17:27:57Z,,0,0,0900006480f80657 FDA-2011-V-0891-0002,FDA,FDA-2011-V-0891,Acknowledgement Letter to Lore2mix,Other,Acknowledgement Letter/Receipt,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T15:26:26Z,,0,0,0900006480f8057f FDA-2011-V-0897-0001,FDA,FDA-2011-V-0897,NLFX Professional - Application for Variance,Other,Application for Variance (VAR),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T17:27:57Z,,0,0,0900006480f80602 FDA-2011-N-0513-0010,FDA,FDA-2011-N-0513,"FDA/OC and ISTA Pharmaceuticals to G. Mathew Warren, FDA Senior Regulatory Counsel, December 16, 2011 - Letter",Other,Letter(s),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T17:27:13Z,,0,0,0900006480f88124 FDA-2011-V-0892-0002,FDA,FDA-2011-V-0892,Acknowledgement Letter to The Boys DJ,Other,Acknowledgement Letter/Receipt,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T16:45:22Z,,0,0,0900006480f80584 FDA-2011-V-0891-0001,FDA,FDA-2011-V-0891,Lore2mix - Application for Variance,Other,Application for Variance (VAR),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T15:26:26Z,,0,0,0900006480f8057d FDA-2010-P-0520-0007,FDA,FDA-2010-P-0520,"FDA/CDER/ to Extremity Innovations, Inc. - Petition Denial",Other,Denial of Petition,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T22:31:18Z,,0,0,0900006480f882c3 FDA-2011-P-0552-0004,FDA,FDA-2011-P-0552,FDA/CDRH Response to Robert Wagner - Petition Denial,Other,Denial of Petition,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T21:35:22Z,,0,0,0900006480f878b0 FDA-2011-P-0645-0003,FDA,FDA-2011-P-0645,FDA/CDER to Center for Inquiry and Committee for Skeptical Inquiry - Petition Denial,Other,Denial of Petition,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T17:22:27Z,,0,0,0900006480f88146 FDA-2011-P-0484-0003,FDA,FDA-2011-P-0484,"Turtle Island Restoration (TIRN), and The Center for Biological Diversity (CBD) - Supplement",Other,Supplement (SUP),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2013-07-28T00:10:37Z,,0,0,0900006480f81d0b FDA-2011-P-0644-0003,FDA,FDA-2011-P-0644,FDA-CDER/ to Center for Inquiry and Committee for Skeptical Inquiry - Petition Denial,Other,Denial of Petition,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T17:08:29Z,,0,0,0900006480f8812b FDA-2011-V-0896-0001,FDA,FDA-2011-V-0896,"Patete Taylor Films, Inc. dba Boulevard Films - Application for Variance",Other,Application for Variance (VAR),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T17:21:12Z,,0,0,0900006480f805fc EPA-HQ-OPP-2010-0659-0003,EPA,EPA-HQ-OPP-2010-0659,Public Participation: New active ingredient Pyriofenone,Other,Public Participation,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,2012-01-22T04:59:59Z,2011-12-21T21:06:27Z,,0,0,0900006480f8741e FDA-2011-V-0877-0002,FDA,FDA-2011-V-0877,Acknowledgement Letter to SLO DJ,Other,Acknowledgement Letter/Receipt,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,,2011-12-21T16:24:34Z,,0,0,0900006480f7c980 FDA-2011-V-0877-0001,FDA,FDA-2011-V-0877,SLO DJ - Application for Variance,Other,Application for Variance (VAR),2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,,2011-12-21T16:24:34Z,,0,0,0900006480f7c961 FDA-2011-P-0804-0003,FDA,FDA-2011-P-0804,"Bruno Independent Living Aids, Inc. - Letter",Other,Letter(s),2011-12-21T05:00:00Z,2011,12,2011-11-09T05:00:00Z,,2013-08-11T04:49:15Z,,0,0,0900006480f7f21f FDA-2011-V-0876-0002,FDA,FDA-2011-V-0876,Acknowledgement Letter to Painted Bride Art Center,Other,Acknowledgement Letter/Receipt,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,,2011-12-21T16:19:26Z,,0,0,0900006480f7c94d FDA-2011-V-0876-0001,FDA,FDA-2011-V-0876,Painted Bride Art Center - Application for Variance,Other,Application for Variance (VAR),2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,,2011-12-21T16:19:25Z,,0,0,0900006480f7c91f FDA-2007-P-0346-0037,FDA,FDA-2007-P-0346,"Richard Sauerheber, Ph.D. - Supplement",Other,Supplement (SUP),2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,,2015-01-13T21:41:40Z,,0,0,0900006480f7e861 FDA-2007-P-0346-0038,FDA,FDA-2007-P-0346,"Richard Sauerheber, Ph.D. - Letter",Other,Letter(s),2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,,2013-07-28T00:10:15Z,,0,0,0900006480f7e863 FDA-2005-N-0404-0551,FDA,FDA-2005-N-0404,University of Nebraska Food Allergy Research & Resource Program - Amendment re FDA-2005-N-0404-0424,Other,Amendment,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2012-03-13T19:15:32Z,,0,0,0900006480f7b9dd FDA-2011-V-0871-0002,FDA,FDA-2011-V-0871,Acknowledgement Letter to Greater Than Entertainment,Other,Acknowledgement Letter/Receipt,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2011-12-20T21:33:08Z,,0,0,0900006480f7c0a8 FDA-2011-D-0476-0010,FDA,FDA-2011-D-0476,Guidance for Industry and Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices,Other,Guidance,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2020-04-29T14:40:32Z,,0,0,0900006480f8692a FDA-2011-V-0874-0002,FDA,FDA-2011-V-0874,"Acknowledgement Letter to RZI, Inc.",Other,Acknowledgement Letter/Receipt,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2024-11-12T04:22:35Z,,1,0,0900006480f7c0da FDA-2011-V-0870-0002,FDA,FDA-2011-V-0870,Acknowledgement Letter to MSA Lighting & Sound LLC,Other,Acknowledgement Letter/Receipt,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2011-12-20T21:27:26Z,,0,0,0900006480f7bf33 FDA-2011-V-0870-0001,FDA,FDA-2011-V-0870,MSA Lighting & Sound LLC - Application for Variance,Other,Application for Variance (VAR),2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2011-12-20T21:27:26Z,,0,0,0900006480f7bf31 FDA-2011-P-0869-0001,FDA,FDA-2011-P-0869,"Hyman, Phelps & McNamara, P.C. - Citizen Petition",Other,Citizen Petition,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2013-09-23T16:02:40Z,,0,0,0900006480f7b83d FDA-2011-V-0874-0001,FDA,FDA-2011-V-0874,"RZI, Inc. - Application for Variance",Other,Application for Variance (VAR),2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2012-09-17T13:58:57Z,,0,0,0900006480f7c0d4 FDA-2011-V-0873-0002,FDA,FDA-2011-V-0873,"Acknowledgement Letter to PMMG, Inc.",Other,Acknowledgement Letter/Receipt,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2011-12-20T21:40:17Z,,0,0,0900006480f7c0ad FDA-2011-P-0869-0002,FDA,FDA-2011-P-0869,"Acknowledgement Letter to Hyman, Phelps & McNamara, P.C.",Other,Acknowledgement Letter/Receipt,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2011-12-20T20:16:33Z,,0,0,0900006480f7b840 FDA-2011-V-0875-0001,FDA,FDA-2011-V-0875,Mt. Hood Skibowl - Application for Variance,Other,Application for Variance (VAR),2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2011-12-20T21:53:40Z,,0,0,0900006480f7c0fe FDA-2011-V-0873-0001,FDA,FDA-2011-V-0873,"PMMG, Inc. - Application for Variance",Other,Application for Variance (VAR),2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2011-12-20T21:40:17Z,,0,0,0900006480f7c0aa FDA-2011-V-0871-0001,FDA,FDA-2011-V-0871,Greater Than Entertainment - Application for Variance,Other,Application for Variance (VAR),2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2011-12-20T21:33:08Z,,0,0,0900006480f7bf36 FDA-2011-V-0875-0002,FDA,FDA-2011-V-0875,Acknowledgement Letter to Mt. Hood Skibowl,Other,Acknowledgement Letter/Receipt,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2011-12-20T21:53:40Z,,0,0,0900006480f7c919 FDA-1997-S-0006-1131,FDA,FDA-1997-S-0006,"Nutrition21, LET1131 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-19T05:00:00Z,2011,12,2011-12-19T05:00:00Z,,2011-12-28T16:20:17Z,,0,0,0900006480f85d05 FDA-1997-S-0006-1127,FDA,FDA-1997-S-0006,"Thuan Hoa Hang, Inc., LET1127 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-19T05:00:00Z,2011,12,2011-12-19T05:00:00Z,,2012-04-02T20:13:13Z,,0,0,0900006480f854b9 FDA-1997-S-0006-1130,FDA,FDA-1997-S-0006,"Country Life, LET1130 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-19T05:00:00Z,2011,12,2011-12-19T05:00:00Z,,2011-12-19T19:08:42Z,,0,0,0900006480f85d03 FDA-1997-S-0006-1126,FDA,FDA-1997-S-0006,"Natural Alternatives for Healthy Living, LET1126 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-19T05:00:00Z,2011,12,2011-12-19T05:00:00Z,,2012-04-02T20:12:33Z,,0,0,0900006480f854b5 FDA-1997-S-0006-1128,FDA,FDA-1997-S-0006,"NBTY, Inc., LET1128 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-19T05:00:00Z,2011,12,2011-12-19T05:00:00Z,,2012-04-02T20:13:54Z,,0,0,0900006480f854bb FDA-2011-D-0817-0002,FDA,FDA-2011-D-0817,"Draft Guidance for Industry and Food and Drug Administration Staff, Evaluation of Sex Differences in Medical Device Clinical Studies",Other,Guidance,2011-12-19T05:00:00Z,2011,12,2011-12-19T05:00:00Z,,2011-12-19T19:08:15Z,,0,0,0900006480f85b9c FDA-1997-S-0006-1129,FDA,FDA-1997-S-0006,"Nutramax Laboratories, Inc., LET1129 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-19T05:00:00Z,2011,12,2011-12-19T05:00:00Z,,2011-12-19T18:46:30Z,,0,0,0900006480f85d01 FDA-2011-P-0482-0003,FDA,FDA-2011-P-0482,"FDA/CDER Interim Response to Novo Nordisk, Inc. - Letter",Other,Letter(s),2011-12-16T05:00:00Z,2011,12,2011-12-16T05:00:00Z,,2011-12-17T00:49:35Z,,0,0,0900006480f844a9 EPA-HQ-OPP-2011-0988-0001,EPA,EPA-HQ-OPP-2011-0988,"Public Participations for New Active Ingredient Bacillus thuringiensis Cry1Ab, Cry2Ae and TwinLink PIPs",Other,Public Participation,2011-12-15T05:00:00Z,2011,12,2011-12-15T05:00:00Z,2012-01-14T04:59:59Z,2012-01-15T13:01:01Z,,0,0,0900006480f8374b FDA-2011-M-0796-0001,FDA,FDA-2011-M-0796,"Abbott Vascular, Inc., Xience Prime and Xience Prime LL Everolimus-Eluting Coronary Stent System, P110019 - Premarket Approval",Other,Approval,2011-12-15T05:00:00Z,2011,12,2011-12-15T05:00:00Z,,2011-12-15T22:04:42Z,,0,0,0900006480f670d8 FDA-2011-P-0473-0004,FDA,FDA-2011-P-0473,"Interim Response to Varam, Inc. c/o: KVK-Tech, Inc. - Letter",Other,Letter(s),2011-12-13T05:00:00Z,2011,12,2011-12-13T05:00:00Z,,2011-12-13T22:50:11Z,,0,0,0900006480f81c54 FDA-2011-D-0847-0002,FDA,FDA-2011-D-0847,Draft Guidance for Industry and Staff; Humanitarian Use Device Designations,Other,Guidance,2011-12-13T05:00:00Z,2011,12,2011-12-13T05:00:00Z,,2024-11-07T01:39:22Z,,1,0,0900006480f815fc FDA-2011-P-0646-0003,FDA,FDA-2011-P-0646,"Interim Response to City of Philadephia, Department of Public Health - Letter",Other,Letter(s),2011-12-13T05:00:00Z,2011,12,2011-12-13T05:00:00Z,,2011-12-13T22:33:45Z,,0,0,0900006480f81bf5 FDA-2011-M-0792-0001,FDA,FDA-2011-M-0792,"APTIMA HPV Assay, P110042 - Permarket Approval",Other,Approval,2011-12-12T05:00:00Z,2011,12,2011-12-12T05:00:00Z,,2011-12-12T17:14:55Z,,0,0,0900006480f658fa FDA-2009-M-0101-0040,FDA,FDA-2009-M-0101,Philips Medical Systems Cardiac Care - Petition for Reclassification,Other,Change in Classification Petition,2011-12-12T05:00:00Z,2011,12,2011-12-12T05:00:00Z,,2013-07-28T00:10:31Z,,0,0,0900006480f80aac FDA-2011-P-0455-0004,FDA,FDA-2011-P-0455,Interim Response to Public Citizen's Health Research Group - Letter,Other,Letter(s),2011-12-12T05:00:00Z,2011,12,2011-12-12T05:00:00Z,,2011-12-12T15:41:09Z,,0,0,0900006480f80646