documents

Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

18,435 rows where agency_id = "FDA" and posted_year = 2016 sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

Suggested facets: posted_month, open_for_comment, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

document_type 5

posted_year 1

  • 2016 · 18,435 ✖

agency_id 1

  • FDA · 18,435 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 Botanical Drug Development 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 Botanical Drug Development 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

Next page

Advanced export

JSON shape: default, array, newline-delimited, object

CSV options: 

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);