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withdrawn,object_id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-2016-D-2335-0731,FDA,FDA-2016-D-2335,Use of the Term Healthy in the Labeling of Human Food Products; Request for Information and Comments; Extension of Comment Period,Proposed Rule,Extension of Comment Period,2016-12-30T05:00:00Z,2016,12,2016-12-30T05:00:00Z,2017-04-27T03:59:59Z,2017-04-27T13:02:53Z,2016-31734,0,0,090000648244128d
FDA-2014-N-1205-0019,FDA,FDA-2014-N-1205,"Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems",Rule,Final Rule,2016-12-30T05:00:00Z,2016,12,2016-12-30T05:00:00Z,,2016-12-30T14:11:28Z,2016-31670,0,0,0900006482441325
FDA-2014-N-1205-0027,FDA,FDA-2014-N-1205,"Reference 9 - DeIure 2012 Posterior lumbar fusion by peek rods in degenerative spine: preliminary report on 30 cases re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems",Supporting & Related Material,Background Material,2016-12-30T05:00:00Z,2016,12,,,2016-12-30T15:24:47Z,,0,0,0900006482441a70
FDA-2014-N-1205-0028,FDA,FDA-2014-N-1205,"Reference  10 - Ormond 2016 Polyetheretherketone (PEEK) Rods in Lumbar Spine Degenerative Disease A Case Series re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems",Supporting & Related Material,Background Material,2016-12-30T05:00:00Z,2016,12,,,2016-12-30T15:24:50Z,,0,0,0900006482441a76
FDA-2011-D-0376-2012,FDA,FDA-2011-D-0376,Attachment 1 Comments from Various Organization in Reference to New Dietary Ingredient Notifications and Related Issues re: Comment from Thorne Research,Supporting & Related Material,Background Material,2016-12-30T05:00:00Z,2016,12,,,2016-12-30T16:17:33Z,,0,0,0900006482441f42
FDA-2013-N-1155-0004,FDA,FDA-2013-N-1155,Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations,Notice,60 Day Proposed Information Collection,2016-12-30T05:00:00Z,2016,12,2016-12-30T05:00:00Z,2017-03-01T04:59:59Z,2017-04-26T12:10:50Z,2016-31733,0,0,0900006482441427
FDA-2011-F-0172-0620,FDA,FDA-2011-F-0172,"Food Labeling:Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Final Regulatory Impact Analysis
FDA–2011–F–0172",Supporting & Related Material,Background Material,2016-12-30T05:00:00Z,2016,12,,,2016-12-30T14:42:43Z,,0,0,0900006482441831
FDA-2016-N-0124-0256,FDA,FDA-2016-N-0124,Advice Letter from FDA CDER to American Chemistry Council,Supporting & Related Material,Letter,2016-12-30T05:00:00Z,2016,12,,,2016-12-30T18:09:27Z,,0,0,0900006482442593
FDA-2011-F-0172-0619,FDA,FDA-2011-F-0172,Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date,Rule,Final Rule,2016-12-30T05:00:00Z,2016,12,2016-12-30T05:00:00Z,,2016-12-30T13:58:42Z,2016-31597,0,0,09000064824412de
FDA-2014-N-1205-0025,FDA,FDA-2014-N-1205,"Reference 7 - Athanasakopoulos 2013 Posterior Spinal Fusion Using Pedicle Screws re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems",Supporting & Related Material,Background Material,2016-12-30T05:00:00Z,2016,12,,,2016-12-30T15:24:41Z,,0,0,0900006482441a6d
FDA-2014-N-1205-0030,FDA,FDA-2014-N-1205,"Reference  11 - Yang 2014 Short term outcome of posterior dynamic stabilization system in degenerative lumbar diseases re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems",Supporting & Related Material,Background Material,2016-12-30T05:00:00Z,2016,12,,,2016-12-30T15:24:57Z,,0,0,0900006482441a7a
FDA-2014-N-1205-0024,FDA,FDA-2014-N-1205,"Reference 6 - Gornet 2011 Biomechanical Assessment of a PEEK Rod System for Semi-Rigid Fixation of Lumbar Fusion Constructs re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems",Supporting & Related Material,Background Material,2016-12-30T05:00:00Z,2016,12,,,2016-12-30T15:24:37Z,,0,0,0900006482441a6b
FDA-2014-N-1205-0029,FDA,FDA-2014-N-1205,"Reference 10.1 - Ormond 2012 Polyetheretherketone (PEEK) Rods in Lumbar Spine Degenerative Disease: A Case Series re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems",Supporting & Related Material,Background Material,2016-12-30T05:00:00Z,2016,12,,,2016-12-30T15:24:53Z,,0,0,0900006482441a79
FDA-2015-N-0101-1319,FDA,FDA-2015-N-0101,Advice Letter from FDA CDER to American Chemistry Council,Other,Letter(s),2016-12-30T05:00:00Z,2016,12,2016-12-30T05:00:00Z,,2016-12-30T18:11:04Z,,0,0,0900006482442595
FDA-2016-F-3880-0002,FDA,FDA-2016-F-3880,"Novus International, Inc.; Filing of Food Additive Petition (Animal Use);
Reopening of the Comment Period",Proposed Rule,Reopening of Comment Period,2016-12-30T05:00:00Z,2016,12,2016-12-30T05:00:00Z,2017-01-31T04:59:59Z,2017-01-31T14:01:36Z,2016-31606,0,0,090000648244128b
FDA-2014-N-1205-0021,FDA,FDA-2014-N-1205,"Reference 3 - Qi 2013 Comparative effectiveness of PEEK rods versus titanium alloy rods in lumbar fusion: A preliminary report re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems",Supporting & Related Material,Background Material,2016-12-30T05:00:00Z,2016,12,,,2016-12-30T15:24:27Z,,0,0,0900006482441a68
FDA-2014-N-1205-0022,FDA,FDA-2014-N-1205,"Reference 4 - Sengupta 2013 The Comprehensive Biomechanics and Load-Sharing of Semirigid PEEK and Semirigid Posterio Dynamic Stabilizations Systems re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems",Supporting & Related Material,Background Material,2016-12-30T05:00:00Z,2016,12,,,2016-12-30T15:24:30Z,,0,0,0900006482441a69
FDA-2014-N-1205-0026,FDA,FDA-2014-N-1205,"Reference 8 - Colangeli 2015 Polyetheretherketone (PEEK) rods: short-term results in lumbar spine degenerative disease re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems",Supporting & Related Material,Background Material,2016-12-30T05:00:00Z,2016,12,,,2016-12-30T15:24:44Z,,0,0,0900006482441a6e
FDA-2015-D-0025-0015,FDA,FDA-2015-D-0025,Medical Device Accessories—Describing Accessories and Classification Pathway for New Accessory Types; Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2016-12-30T05:00:00Z,2016,12,2016-12-30T05:00:00Z,,2016-12-30T14:17:49Z,2016-31669,0,0,0900006482441379
FDA-2015-D-0025-0016,FDA,FDA-2015-D-0025,Medical Device Accessories – Describing Accessories and Classification Pathway for New Accessory Types Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2016-12-30T05:00:00Z,2016,12,2016-12-30T05:00:00Z,,2024-11-11T21:31:30Z,,1,0,09000064824410cc
FDA-2014-N-1205-0020,FDA,FDA-2014-N-1205,"Reference 1 - Matsuzaki 1990 Problems and Solutions of Pedicle Screw Plate Fixation of Lumbar Spine re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems",Supporting & Related Material,Background Material,2016-12-30T05:00:00Z,2016,12,,,2016-12-30T15:24:24Z,,0,0,0900006482441a67
FDA-2014-N-1205-0023,FDA,FDA-2014-N-1205,"Reference 5 - Kurtz 2013 Retrieval analysis of PEEK rods for posterior fusion and motion preservation re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems",Supporting & Related Material,Background Material,2016-12-30T05:00:00Z,2016,12,,,2016-12-30T15:24:34Z,,0,0,0900006482441a6a
FDA-2016-P-4388-0004,FDA,FDA-2016-P-4388,Citizen Petition Reference List Re. Citizen Petition from S. Varghese,Supporting & Related Material,Background Material,2016-12-29T05:00:00Z,2016,12,,,2016-12-29T17:34:01Z,,0,0,090000648243acf8
FDA-2016-D-0269-0113,FDA,FDA-2016-D-0269,"Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry",Other,Guidance,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2024-11-12T06:18:06Z,,1,0,090000648243ddab
FDA-2013-N-0879-0004,FDA,FDA-2013-N-0879,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products",Notice,30 Day Proposed Information Collection,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,2017-01-31T04:59:59Z,2017-01-31T02:00:17Z,2016-31424,0,0,090000648243d253
FDA-2016-P-4388-0003,FDA,FDA-2016-P-4388,"Baker, a Pharmacological Review 2007 Re. Citizen Petition from S. Varghese",Supporting & Related Material,Background Material,2016-12-29T05:00:00Z,2016,12,,,2016-12-29T17:33:57Z,,0,0,090000648243acf7
FDA-2016-D-4318-0001,FDA,FDA-2016-D-4318,"Compounding and Repackaging of Radiopharmaceuticals by State-
Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for
Industry; Availability",Notice,Notice of Availability,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T14:29:37Z,2016-31513,0,0,090000648243d2fb
FDA-2013-E-0397-0007,FDA,FDA-2013-E-0397,Letter from U.S. Patent and Trademark Office,Other,Letter(s),2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T17:24:51Z,,0,0,090000648243dfe0
FDA-2016-V-4616-0002,FDA,FDA-2016-V-4616,Acknowledgement Letter from FDA DDM to LASERSLIVE,Other,Acknowledgement Letter/Receipt,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T22:41:32Z,,0,0,090000648243f2c9
FDA-2016-V-4592-0002,FDA,FDA-2016-V-4592,Acknowledgement Letter from FDA DDM to FOH Ninja,Other,Acknowledgement Letter/Receipt,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T22:38:52Z,,0,0,090000648243c203
FDA-2014-E-0265-0008,FDA,FDA-2014-E-0265,Letter from U.S. Patent and Trademark Office,Other,Letter(s),2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T17:00:31Z,,0,0,090000648243db42
FDA-2000-D-0103-0010,FDA,FDA-2000-D-0103,Botanical Drug Development Guidance for Industry,Other,Guidance,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2024-11-12T06:17:07Z,,1,0,090000648243ddaf
FDA-2016-V-4616-0001,FDA,FDA-2016-V-4616,Variance Application from LASERSLIVE,Other,Application for Variance (VAR),2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T22:40:37Z,,0,0,090000648243f28d
FDA-2013-E-0687-0007,FDA,FDA-2013-E-0687,Letter from U.S. Patent and Trademark Office,Other,Letter(s),2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T17:16:50Z,,0,0,090000648243df84
FDA-2016-N-1555-0007,FDA,FDA-2016-N-1555,Refuse to Accept Procedures for Premarket Tobacco Product Submissions,Rule,Final Rule,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T15:14:13Z,2016-31370,0,0,090000648243d41a
FDA-2000-D-0103-0009,FDA,FDA-2000-D-0103,Botanical Drug Development; Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T14:39:34Z,2016-31627,0,0,090000648243d468
FDA-2009-D-0524-0032,FDA,FDA-2009-D-0524,Listing of Ingredients in Tobacco Products; Revised Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T15:34:59Z,2016-31587,0,0,090000648243d2a5
FDA-2016-N-0002-0035,FDA,FDA-2016-N-0002,"Abbott Laboratories, et al.; Withdrawal of Approval of Four New Drug
Applications and Two Abbreviated New Drug Applications",Notice,Withdrawal,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T15:02:22Z,2016-31625,0,0,090000648243d2a9
FDA-2016-P-4388-0005,FDA,FDA-2016-P-4388,Loperamide Abuse and Dependence 2015 Re. Citizen Petition from S. Varghese,Supporting & Related Material,Background Material,2016-12-29T05:00:00Z,2016,12,,,2016-12-29T17:34:05Z,,0,0,090000648243acf9
FDA-2016-P-4388-0006,FDA,FDA-2016-P-4388,"Loperamide Induced TDP, Re. Citizen Petition from S. Varghese",Supporting & Related Material,Background Material,2016-12-29T05:00:00Z,2016,12,,,2016-12-29T17:34:08Z,,0,0,090000648243acfa
FDA-2016-N-3389-0394,FDA,FDA-2016-N-3389,Request to Extend Comment Period from Grocery Manufacturers Association,Other,Electronic Regulation from Form,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T17:19:26Z,,0,0,0900006482432fb6
FDA-2016-D-4317-0002,FDA,FDA-2016-D-4317,Draft Guidance for Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry,Other,Guidance,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,2017-02-28T04:59:59Z,2019-08-21T15:09:05Z,,0,0,090000648243ddb2
FDA-2016-V-4617-0001,FDA,FDA-2016-V-4617,Variance Application from Redwolf Entertainment,Other,Application for Variance (VAR),2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T23:09:01Z,,0,0,090000648243f1f6
FDA-2016-D-2335-0730,FDA,FDA-2016-D-2335,"Request to Extend Comment Period from Herbalife International of America, Inc.",Other,Request for Extension,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T18:07:39Z,,0,0,0900006482432aa1
FDA-2016-D-2495-0014,FDA,FDA-2016-D-2495,Submission of Warning Plans for Cigars Guidance for Industry,Other,Guidance,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2024-11-07T23:52:28Z,,1,0,090000648243da71
FDA-2016-V-4592-0001,FDA,FDA-2016-V-4592,Variance Application from FOH Ninja,Other,Application for Variance (VAR),2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T22:38:47Z,,0,0,090000648243c201
FDA-2014-E-0126-0011,FDA,FDA-2014-E-0126,Letter from U.S. Patent and Trademark Office,Other,Letter(s),2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T17:22:08Z,,0,0,090000648243dfb9
FDA-2016-V-4617-0002,FDA,FDA-2016-V-4617,Acknowledgement Letter from FDA DDM to Redwolf Entertainment,Other,Acknowledgement Letter/Receipt,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T23:09:07Z,,0,0,090000648243f1f9
FDA-2016-D-2495-0013,FDA,FDA-2016-D-2495,Submission of Warning Plans for Cigars; Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T14:48:32Z,2016-31586,0,0,090000648243d469
FDA-2014-D-0234-0029,FDA,FDA-2014-D-0234,Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product; Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T14:18:33Z,2016-31511,0,0,090000648243d24e
FDA-2013-E-0968-0007,FDA,FDA-2013-E-0968,Letter from U.S. Patent and Trademark Office,Other,Letter(s),2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T17:27:19Z,,0,0,090000648243dfe2
FDA-2013-E-0785-0007,FDA,FDA-2013-E-0785,Letter from U.S. Patent and Trademark Office,Other,Letter(s),2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T17:29:41Z,,0,0,090000648243dfe5
FDA-2014-D-0234-0030,FDA,FDA-2014-D-0234,Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product Guidance for Industry,Other,Guidance,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2024-11-12T06:15:55Z,,1,0,090000648243d98f
FDA-2016-D-4318-0002,FDA,FDA-2016-D-4318,"Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry
DRAFT GUIDANCE",Other,Guidance,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,2017-02-28T04:59:59Z,2024-11-12T06:15:53Z,,1,0,090000648243dd0f
FDA-2013-E-1302-0007,FDA,FDA-2013-E-1302,Letter from U.S. Patent and Trademark Office,Other,Letter(s),2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T17:19:45Z,,0,0,090000648243dfb6
FDA-2016-D-0269-0112,FDA,FDA-2016-D-0269,"Prescription Requirement Under Section 503A of the Federal Food,
Drug, and Cosmetic Act; Guidance for Industry; Availability",Notice,Notice of Availability,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T14:33:49Z,2016-31607,0,0,090000648243d35a
FDA-2016-P-4388-0002,FDA,FDA-2016-P-4388,Acknowledgment Letter from FDA DDM to Dr. S. Varghese,Other,Acknowledgement Letter/Receipt,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T17:33:53Z,,0,0,090000648240c140
FDA-2013-E-0475-0007,FDA,FDA-2013-E-0475,Letter from U.S. Patent and Trademark Office,Other,Letter(s),2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T17:06:41Z,,0,0,090000648243db48
FDA-2016-P-4388-0001,FDA,FDA-2016-P-4388,Citizen Petition from Dr. S. Varghese,Other,Citizen Petition,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,2017-06-27T03:59:59Z,2020-12-11T15:25:03Z,,0,0,090000648240c13d
FDA-2009-D-0524-0033,FDA,FDA-2009-D-0524,Listing of Ingredients in Tobacco Products (Revised)* Guidance for Industry,Other,Guidance,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2024-11-11T21:31:27Z,,1,0,090000648243d90e
FDA-2014-E-0102-0010,FDA,FDA-2014-E-0102,Letter from U.S. Patent and Trademark Office,Other,Letter(s),2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T17:09:08Z,,0,0,090000648243df82
FDA-2016-P-4388-0007,FDA,FDA-2016-P-4388,"Poor man's Methadone, Re. Citizen Petition from S. Varghese",Supporting & Related Material,Background Material,2016-12-29T05:00:00Z,2016,12,,,2016-12-29T17:34:12Z,,0,0,090000648243acfb
FDA-2016-D-4317-0001,FDA,FDA-2016-D-4317,Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T14:53:06Z,2016-31512,0,0,090000648243d4ab
FDA-2016-N-0001-0129,FDA,FDA-2016-N-0001,"Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products; Public Workshop",Notice,Public Meetings,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T14:11:28Z,2016-31628,0,0,090000648243d171
FDA-2014-D-1953-0002,FDA,FDA-2014-D-1953,"Providing Regulatory Submissions in Electronic Format—Submission of
Manufacturing Establishment Information; Draft Guidance for Industry; Availability",Notice,,2016-12-29T00:00:00Z,2016,12,,,2019-05-22T14:57:37Z,,0,1,090000648243d173
FDA-2014-D-1953-0003,FDA,FDA-2014-D-1953,Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information Guidance for Industry,Other,,2016-12-29T00:00:00Z,2016,12,,,2024-11-12T06:18:05Z,,0,1,090000648243d87f
FDA-2016-P-4584-0011,FDA,FDA-2016-P-4584,"Glucuronidation Converts Clopidogrel to a Strong Time-Dependent Inhibitor of CYP2C8: A Phase II Metabolite as a Perpetrator of Drug–Drug
Interactions re Citizen Petition from Public Citizens Health Research Group",Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:50:35Z,,0,0,090000648243b759
FDA-2016-P-4587-0001,FDA,FDA-2016-P-4587,Citizen Petition from Mallinckrodt Pharmaceuticals,Other,Citizen Petition,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,2017-06-27T03:59:59Z,2017-05-13T21:06:17Z,,0,0,090000648243b8f5
FDA-2013-E-1652-0007,FDA,FDA-2013-E-1652,Letter from U.S. Patent and Trademark Office to CDER,Other,Letter(s),2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T15:40:58Z,,0,0,090000648243b099
FDA-2013-E-1435-0007,FDA,FDA-2013-E-1435,Notice of Final Determination Letter from U.S. Patent and Trademark Office to CDER,Other,Letter(s),2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T13:27:17Z,,0,0,090000648243a249
FDA-2016-P-4584-0001,FDA,FDA-2016-P-4584,Citizen Petition from Public Citizens Health Research Group,Other,Citizen Petition,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,2017-05-31T03:59:59Z,2016-12-28T21:49:56Z,,0,0,090000648243b3c0
FDA-2014-P-1685-0004,FDA,FDA-2014-P-1685,Petition Denial Letter,Other,Denial of Petition,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T18:59:58Z,,0,0,090000648243b95d
FDA-2016-P-4584-0007,FDA,FDA-2016-P-4584,Clopidogrel - 2016-09 re Citizen Petition from Public Citizens Health Research Group,Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:50:20Z,,0,0,090000648243b755
FDA-2016-P-4584-0008,FDA,FDA-2016-P-4584,Health Canada Warning Repaglinide Jul 2015 re Citizen Petition from Public Citizens Health Research Group,Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:50:23Z,,0,0,090000648243b756
FDA-2016-E-1179-0006,FDA,FDA-2016-E-1179,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: IMLYGIC,Notice,Determinations,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,2017-06-27T03:59:59Z,2016-12-28T14:27:41Z,2016-31322,0,0,090000648243a972
FDA-2016-P-4587-0006,FDA,FDA-2016-P-4587,"Exhibit D Praxair Distribution, Inc. v. INO Therapeutics, LLC,
IPR2015-00884 (Patent 8,291,904 B2); IPR2015-00888 (Patent
8,776,794 B2); IPR2015-00889 (Patent 8,573,209 B2); IPR2015-00891
(Patent 8,573,210 B2); IPR2015-00893 (Patent 8,776795 B2),
Transcript of Proceedings May 16, 2016 re Citizen Petition from Mallinckrodt Pharmaceuticals",Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:51:32Z,,0,0,090000648243b8fc
FDA-2016-P-4584-0006,FDA,FDA-2016-P-4584,Carilion-Prandin Label Aug 2016 re Citizen Petition from Public Citizens Health Research Group,Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:50:17Z,,0,0,090000648243b754
FDA-2016-P-4587-0009,FDA,FDA-2016-P-4587,"Exhibit G Praxair Distribution, Inc. vs. Mallinckrodt Hospital Products IP Ltd, IPR 2015-00893 (Patent: 8,776,795 B2), Petitioner’s Reply to Patent Owners Response, Feb. 24, 2016 re Citizen Petition from Mallinckrodt Pharmaceuticals",Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:51:41Z,,0,0,090000648243b92e
FDA-2016-P-4584-0004,FDA,FDA-2016-P-4584,Canadian drug label - clopidogrel 2016-06 re Citizen Petition from Public Citizens Health Research Group,Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:50:11Z,,0,0,090000648243b3c5
FDA-2014-E-0307-0008,FDA,FDA-2014-E-0307,Notice of Final Determination Letter from U.S. Patent and Trademark Office to CDER,Other,Letter(s),2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T14:15:11Z,,0,0,090000648243a443
FDA-2013-E-1437-0007,FDA,FDA-2013-E-1437,Noice of FInal Determination Letter from U.S. Patent and Trademark Office to CDER,Other,Letter(s),2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T13:58:12Z,,0,0,090000648243a43d
FDA-2016-P-4585-0001,FDA,FDA-2016-P-4585,"Citizen Petition from Acorda Therapeutics, Inc",Other,Citizen Petition,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,2017-06-27T03:59:59Z,2016-12-28T21:50:52Z,,0,0,090000648243b802
FDA-2013-E-0218-0004,FDA,FDA-2013-E-0218,Letter from U.S. Patent and Trademark Office to CDER,Other,Letter(s),2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T12:48:16Z,,0,0,0900006482439154
FDA-2014-E-0279-0008,FDA,FDA-2014-E-0279,Notice of Final Determination Letter from U.S. Patent and Trademark Office to CDER,Other,Letter(s),2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T19:22:15Z,,0,0,090000648243b985
FDA-2016-E-1182-0006,FDA,FDA-2016-E-1182,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: IMLYGIC,Notice,Determinations,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,2017-06-27T03:59:59Z,2016-12-28T14:20:56Z,2016-31322,0,0,0900006482439ffb
FDA-2010-N-0067-0003,FDA,FDA-2010-N-0067,"Pharmaceutical Science and Clinical Pharmacology Advisory Committee;
Notice of Meeting; Correction",Notice,Correction,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T14:16:07Z,2016-31391,0,0,0900006482439e88
FDA-2016-E-4590-0001,FDA,FDA-2016-E-4590,"Patent Extension Application from Cooley LLP (on behalf of Collegium Pharmaceutical, Inc)",Other,Letter(s),2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T18:48:24Z,,0,0,090000648243b930
FDA-2016-E-4588-0001,FDA,FDA-2016-E-4588,"Patent Extension Application from Cooley LLP (on behalf of Collegium Pharmaceutical, Inc)",Other,Application,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2017-07-18T11:56:50Z,,0,0,090000648243b645
FDA-2014-E-0182-0008,FDA,FDA-2014-E-0182,Notice of Final Determination Letter from U.S. Patent and Trademark Office to CDER,Other,Letter(s),2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T14:43:08Z,,0,0,090000648243a977
FDA-2016-P-4585-0002,FDA,FDA-2016-P-4585,"Acknowledgement Letter from FDA DDM to Acorda Therapeutics, Inc.",Other,Acknowledgement Letter/Receipt,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T21:50:55Z,,0,0,090000648243b804
FDA-2011-E-0117-0010,FDA,FDA-2011-E-0117,Letter from U.S. Patent and Trademark Office to CDER,Other,Letter(s),2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T16:02:09Z,,0,0,090000648243ac83
FDA-2016-E-1181-0006,FDA,FDA-2016-E-1181,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: IMLYGIC,Notice,Determinations,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,2017-06-27T03:59:59Z,2016-12-28T14:27:57Z,2016-31322,0,0,090000648243a973
FDA-2013-E-1433-0007,FDA,FDA-2013-E-1433,Notice of Final Determination Letter from U.S. Patent and Trademark Office to CDER,Other,Letter(s),2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T19:30:45Z,,0,0,090000648243b987
FDA-2016-E-0629-0004,FDA,FDA-2016-E-0629,Letter from U.S. Patent and Trademark Office to CDER,Other,Letter(s),2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T19:08:09Z,,0,0,090000648243b936
FDA-2014-E-0074-0008,FDA,FDA-2014-E-0074,Letter from U.S. Patent and Trademark Office to CDER,Other,Letter(s),2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T15:15:46Z,,0,0,090000648243af7e
FDA-2016-E-4588-0002,FDA,FDA-2016-E-4588,Letter from U.S. Patent and Trademark Office to CDER,Other,Letter(s),2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T17:45:01Z,,0,0,090000648243b649
FDA-2015-D-5105-0057,FDA,FDA-2015-D-5105,Postmarket Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration; Availability,Notice,Notice of Availability,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T14:24:37Z,2016-31406,0,0,090000648243a197
FDA-2016-P-4587-0007,FDA,FDA-2016-P-4587,"Exhibit E Praxair Distribution, Inc. v. INO Therapeutics, LLC d/b/a Ikaria, Inc., Petition for Inter Partes Review of U.S. Patent No. 8,776,795, March 16, 2015 re Citizen Petition from Mallinckrodt Pharmaceuticals",Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:51:35Z,,0,0,090000648243b8fd
FDA-2016-P-4587-0010,FDA,FDA-2016-P-4587,"Exhibit H Tissue Debate Raises Fairness, Transparency Questions for Combo
Products, The Gray Sheet (4/29/2002) re Citizen Petition from Mallinckrodt Pharmaceuticals",Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:51:44Z,,0,0,090000648243b92f
FDA-2016-P-4584-0009,FDA,FDA-2016-P-4584,Clarification of the Mechanism of Clopidogrel-Mediated Drug-Drug Interaction in a Clinical Cassette Small-dose Study and Its Prediction re Citizen Petition from Public Citizens Health Research Group,Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:50:27Z,,0,0,090000648243b757