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

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15,765 rows where agency_id = "FDA" and posted_year = 2018 sorted by posted_date descending

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  • 2018 · 15,765 ✖

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  • FDA · 15,765 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2017-E-6016-0006 FDA FDA-2017-E-6016 Determination of Regulatory Review Period for Purposes of Patent Extension; PARSABIV Notice Determinations 2018-12-31T05:00:00Z 2018 12 2018-12-31T05:00:00Z 2019-02-27T04:59:59Z 2019-01-09T02:01:46Z 2018-28221 0 0 09000064839d2140
FDA-2017-E-6017-0006 FDA FDA-2017-E-6017 Determination of Regulatory Review Period for Purposes of Patent Extension; PARSABIV Notice Determinations 2018-12-31T05:00:00Z 2018 12 2018-12-31T05:00:00Z 2019-02-27T04:59:59Z 2018-12-31T23:00:56Z 2018-28221 0 0 09000064839d2141
FDA-2017-E-6708-0006 FDA FDA-2017-E-6708 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: RYDAPT Notice Determinations 2018-12-31T05:00:00Z 2018 12 2018-12-31T05:00:00Z 2019-06-27T03:59:59Z 2024-03-07T21:12:00Z 2018-28216 0 0 09000064839d2146
FDA-2015-N-0101-1463 FDA FDA-2015-N-0101 Meeting Granted Letter from FDA CDER to Cardinal Health Other Approval 2018-12-31T05:00:00Z 2018 12 2018-12-31T05:00:00Z   2018-12-31T22:18:50Z   0 0 09000064839d240f
FDA-2017-E-6701-0006 FDA FDA-2017-E-6701 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: RYDAPT Notice Determinations 2018-12-31T05:00:00Z 2018 12 2018-12-31T05:00:00Z 2019-06-27T03:59:59Z 2024-03-07T21:19:56Z 2018-28216 0 0 09000064839d2147
FDA-2016-P-1962-0006 FDA FDA-2016-P-1962 Letter from FDA CDER to Hyman, Phelps, and McNamara, P.C. Other Partial Petition Approval and Denial 2018-12-31T05:00:00Z 2018 12 2018-12-31T05:00:00Z   2018-12-31T22:07:39Z   0 0 09000064839d2016
FDA-2018-H-4831-0001 FDA FDA-2018-H-4831 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T13:16:15Z   0 0 09000064839c9f85
FDA-2018-H-4848-0001 FDA FDA-2018-H-4848 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T15:43:41Z   0 0 09000064839cc441
FDA-2018-H-4820-0001 FDA FDA-2018-H-4820 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T12:38:02Z   0 0 09000064839c9c63
FDA-2018-H-4840-0001 FDA FDA-2018-H-4840 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T16:51:50Z   0 0 09000064839cc8a4
FDA-2018-H-4817-0001 FDA FDA-2018-H-4817 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T12:20:01Z   0 0 09000064839c9c19
FDA-2018-H-4822-0001 FDA FDA-2018-H-4822 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T12:59:16Z   0 0 09000064839ca125
FDA-2018-H-4852-0001 FDA FDA-2018-H-4852 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T15:40:52Z   0 0 09000064839cc629
FDA-2007-D-0369-0459 FDA FDA-2007-D-0369 Product-Specific Guidance for Linaclotide; Draft Guidance for Industry Notice Notice of Availability 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-02-27T04:59:59Z 2019-02-27T02:04:39Z 2018-28213 0 0 09000064839cbf71
FDA-2018-H-4850-0001 FDA FDA-2018-H-4850 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T15:33:00Z   0 0 09000064839cc5da
FDA-2018-H-4844-0001 FDA FDA-2018-H-4844 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T16:40:36Z   0 0 09000064839cca11
FDA-2018-H-4818-0001 FDA FDA-2018-H-4818 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T12:25:19Z   0 0 09000064839c9c34
FDA-2018-H-4855-0001 FDA FDA-2018-H-4855 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T16:56:09Z   0 0 09000064839ccbc2
FDA-2018-H-4809-0001 FDA FDA-2018-H-4809 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T13:32:37Z   0 0 09000064839c9419
FDA-2018-H-4837-0001 FDA FDA-2018-H-4837 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T14:12:19Z   0 0 09000064839cbb58
FDA-2018-H-4830-0001 FDA FDA-2018-H-4830 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T13:12:50Z   0 0 09000064839c9c0b
FDA-2018-H-4835-0001 FDA FDA-2018-H-4835 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T13:27:00Z   0 0 09000064839cb843
FDA-2018-H-4859-0001 FDA FDA-2018-H-4859 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T15:55:17Z   0 0 09000064839cc998
FDA-2017-E-6003-0006 FDA FDA-2017-E-6003 Determination of Regulatory Review Period for Purposes of Patent Extension; PARSABIV Notice Determinations 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-02-27T04:59:59Z 2018-12-31T21:10:48Z 2018-28221 0 0 09000064839cbe98
FDA-2018-D-4662-0001 FDA FDA-2018-D-4662 International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV Notice Notice of Availability 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-02-27T04:59:59Z 2019-01-14T19:29:13Z 2018-28219 0 0 09000064839cbf33
FDA-2018-N-3037-0002 FDA FDA-2018-N-3037 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quantitative Testing for the Development of Food and Drug Administration Communications Notice 30 Day Proposed Information Collection 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-01-29T04:59:59Z 2019-01-10T02:46:59Z 2018-28252 0 0 09000064839cbd39
FDA-2018-H-4836-0001 FDA FDA-2018-H-4836 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T14:10:49Z   0 0 09000064839cc150
FDA-2018-H-4857-0001 FDA FDA-2018-H-4857 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T17:16:40Z   0 0 09000064839ccd6d
FDA-2018-H-4819-0001 FDA FDA-2018-H-4819 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T12:27:47Z   0 0 09000064839c9bca
FDA-2018-H-4808-0001 FDA FDA-2018-H-4808 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T13:31:48Z   0 0 09000064839c95f2
FDA-2018-H-4821-0001 FDA FDA-2018-H-4821 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T12:40:14Z   0 0 09000064839ca0c0
FDA-2018-H-4849-0001 FDA FDA-2018-H-4849 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T15:28:25Z   0 0 09000064839cc537
FDA-2017-E-6736-0005 FDA FDA-2017-E-6736 Determination of Regulatory Review Period for Purposes of Patent Extension; XERMELO Notice Determinations 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-02-27T04:59:59Z 2018-12-31T21:26:53Z 2018-28218 0 0 09000064839cbee3
FDA-2012-N-0197-0005 FDA FDA-2012-N-0197 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Shortages Data Collection System Notice Request for Comments 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-02-27T04:59:59Z 2018-12-31T20:58:41Z 2018-28235 0 0 09000064839cbe96
FDA-2017-E-6002-0006 FDA FDA-2017-E-6002 Determination of Regulatory Review Period for Purposes of Patent Extension; RUBRACA Notice Determinations 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-02-27T04:59:59Z 2018-12-31T21:05:16Z 2018-28217 0 0 09000064839cbe97
FDA-2018-H-4858-0001 FDA FDA-2018-H-4858 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T17:17:18Z   0 0 09000064839ccdd9
FDA-2018-H-4856-0001 FDA FDA-2018-H-4856 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T16:57:22Z   0 0 09000064839ccbdc
FDA-2018-H-4843-0001 FDA FDA-2018-H-4843 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T16:56:45Z   0 0 09000064839ccd08
FDA-2012-N-0536-0008 FDA FDA-2012-N-0536 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 Notice 60 Day Proposed Information Collection 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-02-27T04:59:59Z 2019-07-17T12:49:50Z 2018-28220 0 0 09000064839cc098
FDA-2018-H-4833-0001 FDA FDA-2018-H-4833 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T13:19:51Z   0 0 09000064839cb83d
FDA-2018-H-4861-0001 FDA FDA-2018-H-4861 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T16:11:58Z   0 0 09000064839cca33
FDA-2018-H-4853-0001 FDA FDA-2018-H-4853 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T15:47:44Z   0 0 09000064839cc95c
FDA-2018-H-4834-0001 FDA FDA-2018-H-4834 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T13:23:12Z   0 0 09000064839ca3b1
FDA-2018-H-4854-0001 FDA FDA-2018-H-4854 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T16:41:22Z   0 0 09000064839ccb70
FDA-2017-E-6700-0006 FDA FDA-2017-E-6700 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: RYDAPT Notice Determinations 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-06-27T03:59:59Z 2024-03-07T21:04:21Z 2018-28216 0 0 09000064839cbfba
FDA-2018-H-4842-0001 FDA FDA-2018-H-4842 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T16:54:39Z   0 0 09000064839ccb78
FDA-2018-H-4838-0001 FDA FDA-2018-H-4838 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T14:13:06Z   0 0 09000064839cc18d
FDA-2018-H-4860-0001 FDA FDA-2018-H-4860 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T15:56:00Z   0 0 09000064839cc9cc
FDA-2018-H-4810-0001 FDA FDA-2018-H-4810 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T13:46:22Z   0 0 09000064839c944d
FDA-2018-H-4846-0001 FDA FDA-2018-H-4846 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T15:30:01Z   0 0 09000064839cc502
FDA-2018-H-4847-0001 FDA FDA-2018-H-4847 Complaint Other Complaint 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z   2018-12-28T15:33:36Z   0 0 09000064839cc508
FDA-2018-H-4788-0001 FDA FDA-2018-H-4788 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T13:33:57Z   0 0 09000064839c81e3
FDA-2018-H-4794-0001 FDA FDA-2018-H-4794 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T13:50:26Z   0 0 09000064839c7f4e
FDA-2018-H-4791-0001 FDA FDA-2018-H-4791 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T12:46:32Z   0 0 09000064839c723d
FDA-2018-H-4781-0001 FDA FDA-2018-H-4781 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T12:51:27Z   0 0 09000064839c7235
FDA-2018-H-4797-0001 FDA FDA-2018-H-4797 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T14:06:15Z   0 0 09000064839c7fdf
FDA-2018-H-4803-0001 FDA FDA-2018-H-4803 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T16:57:22Z   0 0 09000064839c8cfd
FDA-2018-H-4829-0001 FDA FDA-2018-H-4829 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T20:13:22Z   0 0 09000064839c9d74
FDA-2017-F-2130-0016 FDA FDA-2017-F-2130 Food Additives Permitted in Feed and Drinking Water of Animals; Formic Acid Rule Final Rule 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-31T20:44:12Z 2018-27966 0 0 09000064839c8864
FDA-2018-H-4795-0001 FDA FDA-2018-H-4795 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T13:57:39Z   0 0 09000064839c7f54
FDA-2018-H-4799-0001 FDA FDA-2018-H-4799 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T15:06:54Z   0 0 09000064839c89ef
FDA-2018-H-4824-0001 FDA FDA-2018-H-4824 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T20:00:22Z   0 0 09000064839c9ab2
FDA-2018-H-4775-0001 FDA FDA-2018-H-4775 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T12:56:05Z   0 0 09000064839c7094
FDA-2018-H-4798-0001 FDA FDA-2018-H-4798 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T14:09:39Z   0 0 09000064839c823d
FDA-2018-H-4796-0001 FDA FDA-2018-H-4796 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T14:02:12Z   0 0 09000064839c7fa8
FDA-2018-H-4786-0001 FDA FDA-2018-H-4786 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T13:10:53Z   0 0 09000064839c6fd5
FDA-2018-H-4784-0001 FDA FDA-2018-H-4784 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T13:25:14Z   0 0 09000064839c6f94
FDA-2018-H-4787-0001 FDA FDA-2018-H-4787 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T13:07:56Z   0 0 09000064839c6fdb
FDA-2018-H-4789-0001 FDA FDA-2018-H-4789 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T13:51:44Z   0 0 09000064839c7fd6
FDA-2018-H-4825-0001 FDA FDA-2018-H-4825 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T20:32:19Z   0 0 09000064839c9bfc
FDA-2018-H-4813-0001 FDA FDA-2018-H-4813 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T19:05:53Z   0 0 09000064839c973d
FDA-2018-N-1989-0001 FDA FDA-2018-N-1989 Ranjan Bhandari: Debarment Order Notice Statutory Debarment 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-31T20:39:45Z 2018-27951 0 0 09000064839c8820
FDA-2018-H-4762-0001 FDA FDA-2018-H-4762 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T13:01:33Z   0 0 09000064839c6e2c
FDA-2018-H-4792-0001 FDA FDA-2018-H-4792 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T12:49:14Z   0 0 09000064839c7265
FDA-2018-H-4807-0001 FDA FDA-2018-H-4807 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T18:10:20Z   0 0 09000064839c9367
FDA-2018-H-4785-0001 FDA FDA-2018-H-4785 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T13:29:51Z   0 0 09000064839c6fc3
FDA-2018-H-4802-0001 FDA FDA-2018-H-4802 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T17:06:32Z   0 0 09000064839c9121
FDA-2018-H-4826-0001 FDA FDA-2018-H-4826 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T20:44:27Z   0 0 09000064839c9c2e
FDA-2018-H-4793-0001 FDA FDA-2018-H-4793 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T13:44:48Z   0 0 09000064839c7b76
FDA-2018-H-4801-0001 FDA FDA-2018-H-4801 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T16:52:09Z   0 0 09000064839c8ea7
FDA-2018-H-4800-0001 FDA FDA-2018-H-4800 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T15:09:05Z   0 0 09000064839c8b0c
FDA-2018-H-4814-0001 FDA FDA-2018-H-4814 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T20:18:22Z   0 0 09000064839c9bd2
FDA-2018-H-4823-0001 FDA FDA-2018-H-4823 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T21:30:43Z   0 0 09000064839ca200
FDA-2018-H-4790-0001 FDA FDA-2018-H-4790 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T13:57:45Z   0 0 09000064839c822f
FDA-2018-H-4806-0001 FDA FDA-2018-H-4806 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T17:42:35Z   0 0 09000064839c91d7
FDA-2018-H-4805-0001 FDA FDA-2018-H-4805 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T17:12:55Z   0 0 09000064839c9127
FDA-2018-H-4811-0001 FDA FDA-2018-H-4811 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T17:01:13Z   0 0 09000064839c8e17
FDA-2018-H-4816-0001 FDA FDA-2018-H-4816 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T20:25:54Z   0 0 09000064839c9bdb
FDA-2018-H-4828-0001 FDA FDA-2018-H-4828 Complaint Other Complaint 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-27T21:27:43Z   0 0 09000064839ca11f
FDA-2018-N-4428-0001 FDA FDA-2018-N-4428 Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application Notice 60 Day Proposed Information Collection 2018-12-26T05:00:00Z 2018 12 2018-12-26T05:00:00Z 2019-02-26T04:59:59Z 2019-01-10T02:17:47Z 2018-27812 0 0 09000064839c4daf
FDA-2018-H-4688-0001 FDA FDA-2018-H-4688 Complaint Other Complaint 2018-12-26T05:00:00Z 2018 12 2018-12-26T05:00:00Z   2018-12-26T20:59:50Z   0 0 09000064839c6c73
FDA-2017-D-3001-0235 FDA FDA-2017-D-3001 Modified Risk Tobacco Product Applications for IQOS System With Marlboro Heatsticks, IQOS System With Marlboro Smooth Menthol Heatsticks, and IQOS System With Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A. Notice Announcement 2018-12-26T05:00:00Z 2018 12 2018-12-26T05:00:00Z 2019-02-12T04:59:59Z 2019-02-27T02:06:18Z 2018-27807 0 0 09000064839c4e5f
FDA-2017-E-5040-0006 FDA FDA-2017-E-5040 Determination of Regulatory Review Period for Purposes of Patent Extension; ADLYXIN Notice Determinations 2018-12-26T05:00:00Z 2018 12 2018-12-26T05:00:00Z 2019-02-26T04:59:59Z 2019-01-10T02:33:03Z 2018-27805 0 0 09000064839c4db3
FDA-2018-H-4782-0001 FDA FDA-2018-H-4782 Complaint Other Complaint 2018-12-26T05:00:00Z 2018 12 2018-12-26T05:00:00Z   2018-12-26T20:18:56Z   0 0 09000064839c6a72
FDA-2014-N-1210-3431 FDA FDA-2014-N-1210 Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses Rule Final Rule 2018-12-26T05:00:00Z 2018 12 2018-12-26T05:00:00Z   2019-01-10T02:12:36Z 2018-27809 0 0 09000064839c4d26
FDA-2018-D-4455-0001 FDA FDA-2018-D-4455 Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Draft Guidance for Industry and Other Stakeholders; Availability Notice Notice of Availability 2018-12-21T05:00:00Z 2018 12 2018-12-21T05:00:00Z 2019-03-22T03:59:59Z 2019-03-23T01:00:52Z 2018-27657 0 0 09000064839be12e
FDA-2017-E-3616-0006 FDA FDA-2017-E-3616 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2018-12-21T05:00:00Z 2018 12 2018-12-21T05:00:00Z   2018-12-21T18:23:37Z   0 0 09000064839c0871
FDA-2016-D-4308-0026 FDA FDA-2016-D-4308 04 Reference 3 Compliance Program Guidance Manual Chapter 42 Blood and Blood Components Inspection of Licensed and Unlicensed Blood Banks Brokers Reference Laboratories and Contractors Supporting & Related Material Background Material 2018-12-21T05:00:00Z 2018 12     2018-12-21T14:36:48Z   0 0 09000064839beb23
FDA-2016-D-4308-0023 FDA FDA-2016-D-4308 01 RBC Antigen_Reference List Supporting & Related Material Background Material 2018-12-21T05:00:00Z 2018 12     2018-12-21T14:34:03Z   0 0 09000064839beb20
FDA-2017-E-5694-0006 FDA FDA-2017-E-5694 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2018-12-21T05:00:00Z 2018 12 2018-12-21T05:00:00Z   2018-12-21T18:17:49Z   0 0 09000064839c07c8

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