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

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

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  • 2016 · 18,435 ✖

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  • 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 Use of the Term “Healthy” in the Labeling of Human Food Products 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 Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems 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 Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems 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 Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems 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 Dietary Supplements: New Dietary Ingredient Notifications and Related Issues 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 Food Labeling Regulations 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 Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments 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 Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record 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 Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments 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 Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems 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 Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems 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 Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems 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 Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems 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 Safety and Effectiveness for Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use 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 Novus International, Inc.; Filing of Food Additive Petition (Animal Use) 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 Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems 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 Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems 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 Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems 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 Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types; Draft Guidance for Industry and Food and Drug Administration Staff 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 Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types; Draft Guidance for Industry and Food and Drug Administration Staff 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 Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems 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 Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems 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 Requests that the FDA to amend the availability of loperamide (Imodium) as non-prescription over the counter (OTC) drug to a prescription drug. 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 Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act 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 Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products 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 Requests that the FDA to amend the availability of loperamide (Imodium) as non-prescription over the counter (OTC) drug to a prescription drug. 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 Compounding and Repackaging of Radiopharmaceuticals By State-Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for Industry; Availability 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 Patent Term Extension Application for iStent® Trabecular Micro-Bypass Stent, U.S. Patent No. 6,626,858 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 Laser Light Show 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 Laser Light Show 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 Patent Term Extension Application for SIRTURO™, Patent No. 7,498,343 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 Laser Light Show 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 Patent Term Extension Application for, AUBAGIO®, U.S. Patent No. 6,794,410 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 Refuse to Accept Procedures for Premarket Tobacco Product Submissions 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 Listing of Ingredients in Tobacco Products 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 NADA/ANADA Notices 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 Requests that the FDA to amend the availability of loperamide (Imodium) as non-prescription over the counter (OTC) drug to a prescription drug. 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 Requests that the FDA to amend the availability of loperamide (Imodium) as non-prescription over the counter (OTC) drug to a prescription drug. 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 Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates 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 Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities; Draft Guidance for Industry; Availability  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 Laser Light Show 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 Use of the Term “Healthy” in the Labeling of Human Food Products 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 Submission of Warning Plans for Cigars 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 Laser Light Show 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 Patent Term Extension Application for Flucelvax, U.S. Patent No. 6,656,720 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 Laser Light Show 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 Submission of Warning Plans for Cigars 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 Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product 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 Patent Term Extension Application for OVUGEL® (Triptorelin accetate), U.S. Patent No. RE 42,072 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 Patent Term Application for RELAY, U.S. Patent No. 8,062,345 B2 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 Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product 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 Compounding and Repackaging of Radiopharmaceuticals By State-Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for Industry; Availability 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 Patent Term Extension Application for, Cameron Health®, S-ICD System (subcutaneous defibrillation syssem), U.S. Patent No. 7,149,575 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 Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act 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 Requests that the FDA to amend the availability of loperamide (Imodium) as non-prescription over the counter (OTC) drug to a prescription drug. 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 Patent Extension Application for STRIBILD Patent No. 7,176,220 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 Requests that the FDA to amend the availability of loperamide (Imodium) as non-prescription over the counter (OTC) drug to a prescription drug. 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 Listing of Ingredients in Tobacco Products 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 Patent Term Extension Application for XIENCE XPEDITION® Coronary Stent System, Patent No. 7,828,766 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 Requests that the FDA to amend the availability of loperamide (Imodium) as non-prescription over the counter (OTC) drug to a prescription drug. 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 Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities; Draft Guidance for Industry; Availability  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 Advisory Committee, Workshops, and Conferences Notices Various Meeting Notices (eg., Task Force Meeting, etc) 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 Guidance for Industry on Providing Regulatory Submissions in Electronic Format - Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act; Availability 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 Guidance for Industry on Providing Regulatory Submissions in Electronic Format - Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act; Availability 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 Request that the FDA take immediate action with respect to: 1. The label of repaglinide-containing medications (PRANDIN, PRANDIMET) include information on a serious drug-drug interaction with clopidogrel (PLAVIX) that could result in severe hypoglycemia; and 2. The labels of both repaglinide-containing medications and clopidogrel include a contraindication to the use of the two drugs together. 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 Requests that the FDA require that all future inhaled nitric oxide drug products and nitric oxide delivery systems be reviewed by the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health in a coordinated fashion. 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 Patent Extension Application for HVAD® Patent No. 6,234,772 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 Patent Term Extension Application for JETREA® (ocriplasmin), U.S. Patent No. 7,445,775 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 Request that the FDA take immediate action with respect to: 1. The label of repaglinide-containing medications (PRANDIN, PRANDIMET) include information on a serious drug-drug interaction with clopidogrel (PLAVIX) that could result in severe hypoglycemia; and 2. The labels of both repaglinide-containing medications and clopidogrel include a contraindication to the use of the two drugs together. 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 Request that the FDA initiate process available through application and applicable regulations to authorize acquisition of oral contraceptive drug products through OTC purchase and eliminate current requirement for sale of an oral contraceptive drug product through OTC purchase and eliminate the current requirement for sale by or on the order of a licensed practitioner 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 Request that the FDA take immediate action with respect to: 1. The label of repaglinide-containing medications (PRANDIN, PRANDIMET) include information on a serious drug-drug interaction with clopidogrel (PLAVIX) that could result in severe hypoglycemia; and 2. The labels of both repaglinide-containing medications and clopidogrel include a contraindication to the use of the two drugs together. 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 Request that the FDA take immediate action with respect to: 1. The label of repaglinide-containing medications (PRANDIN, PRANDIMET) include information on a serious drug-drug interaction with clopidogrel (PLAVIX) that could result in severe hypoglycemia; and 2. The labels of both repaglinide-containing medications and clopidogrel include a contraindication to the use of the two drugs together. 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 Patent Extension Application for IMLYGIC™ Patent No. 7,063,835 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 Requests that the FDA require that all future inhaled nitric oxide drug products and nitric oxide delivery systems be reviewed by the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health in a coordinated fashion. 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 Request that the FDA take immediate action with respect to: 1. The label of repaglinide-containing medications (PRANDIN, PRANDIMET) include information on a serious drug-drug interaction with clopidogrel (PLAVIX) that could result in severe hypoglycemia; and 2. The labels of both repaglinide-containing medications and clopidogrel include a contraindication to the use of the two drugs together. 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 Requests that the FDA require that all future inhaled nitric oxide drug products and nitric oxide delivery systems be reviewed by the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health in a coordinated fashion. 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 Request that the FDA take immediate action with respect to: 1. The label of repaglinide-containing medications (PRANDIN, PRANDIMET) include information on a serious drug-drug interaction with clopidogrel (PLAVIX) that could result in severe hypoglycemia; and 2. The labels of both repaglinide-containing medications and clopidogrel include a contraindication to the use of the two drugs together. 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 Patent Term Extension Application for STIVARGA®, Patent No. 7,351,834 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 Patent Term Application for JETREA®, U.S. Patent No. 7,914,783 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 Request the Food and Drug Administration carefully consider the sufficiency of the identification and qualification of potentially genotoxic impurities in reviewing any ANDA referencing AMPYRA (dalfampridine) Extended Release Tablets. CLOSED 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 Patent Extension Application RECUVYRA™ for Patent No. 6,916,486 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 Patent Term Extension Application for ELIGUIS®, Patent No. 6,967,208 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 Patent Extension Application for IMLYGIC ™ Patent No. 7,537,924 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 Pharmaceutical Science and Clinical Pharmacology 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 Patent Extension Application for XTAMPZA® U.S. Patent No 7,771 ,707 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 Patent Extension Application for XTAMPZA® U.S. Patent No. 8,449,909 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 Patent Term Extension Application for VIZAMYL™, Patent No. 7,270,800 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 Request the Food and Drug Administration carefully consider the sufficiency of the identification and qualification of potentially genotoxic impurities in reviewing any ANDA referencing AMPYRA (dalfampridine) Extended Release Tablets. CLOSED 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 Patent Term Extension Application for PRADAXA® (dabigatran etexilate mesylate), U.S. Patent No. 6,087,380 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 Patent Extension Application for IMLYGIC™ Patent No. 7,223,593 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 Patent Term Extension Application for JETREA®, U.S. Patent No. 7,547,435 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 Patent Extension Application for INTERCEPT® Patent No. 7,611,831 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 Patent Term Extension Application for BOSULIF® (bosutinib monohydrate), Patent No. RE42376 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 Patent Extension Application for XTAMPZA® U.S. Patent No. 8,449,909 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 Postmarket Management of Cybersecurity in Medical Devices 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 Requests that the FDA require that all future inhaled nitric oxide drug products and nitric oxide delivery systems be reviewed by the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health in a coordinated fashion. 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 Requests that the FDA require that all future inhaled nitric oxide drug products and nitric oxide delivery systems be reviewed by the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health in a coordinated fashion. 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 Request that the FDA take immediate action with respect to: 1. The label of repaglinide-containing medications (PRANDIN, PRANDIMET) include information on a serious drug-drug interaction with clopidogrel (PLAVIX) that could result in severe hypoglycemia; and 2. The labels of both repaglinide-containing medications and clopidogrel include a contraindication to the use of the two drugs together. 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

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