id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2011-N-0902-0014,FDA,FDA-2011-N-0902,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,,2019-12-31T14:53:14Z,2019-28249,0,0,090000648425db88
FDA-2018-N-4839-0003,FDA,FDA-2018-N-4839,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,,2019-12-31T14:56:25Z,2019-28249,0,0,090000648425d8b1
FDA-2013-N-0662-0009,FDA,FDA-2013-N-0662,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,,2019-12-31T14:53:40Z,2019-28249,0,0,090000648425db89
FDA-2019-N-5955-0001,FDA,FDA-2019-N-5955,International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; AB-FUBINACA; 5FAMB- PINACA; 5F-MDMB-PICA; 4-FMDMB- BINACA; 4-CMC; Nethylhexedrone; alpha-PHP; DOC; Crotonyl Fentanyl; Valeryl Fentanyl; Flualprazolam and Etizolam; Request for Comments,Notice,Request for Comments,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,2020-01-31T04:59:59Z,2020-02-01T02:02:04Z,2019-28269,0,0,090000648425d40c
FDA-2019-P-3877-0003,FDA,FDA-2019-P-3877,"Determination That GLUCOPHAGE (Metformin Hydrochloride) Oral Tablets, 500 Milligrams, 850 Milligrams, and 1 Gram, and GLUCOPHAGE XR (Metformin Hydrochloride) Oral Extended-Release Tablets, 500 Milligrams and 750 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,,2019-12-31T14:31:28Z,2019-28270,0,0,090000648425d320
FDA-2019-N-0549-0011,FDA,FDA-2019-N-0549,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,,2019-12-31T14:54:45Z,2019-28249,0,0,090000648425d866
FDA-2016-N-3586-0005,FDA,FDA-2016-N-3586,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups About Drug Products as Used by the Food and Drug Administration,Notice,30 Day Proposed Information Collection,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,2020-01-31T04:59:59Z,2019-12-31T14:36:48Z,2019-28247,0,0,090000648425d323
FDA-2013-N-0134-0149,FDA,FDA-2013-N-0134,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,,2019-12-31T14:47:33Z,2019-28249,0,0,090000648425d409
FDA-2013-N-0242-0015,FDA,FDA-2013-N-0242,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,,2019-12-31T14:54:02Z,2019-28249,0,0,090000648425db8d
FDA-2019-N-1517-0005,FDA,FDA-2019-N-1517,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,,2019-12-31T14:54:26Z,2019-28249,0,0,090000648425d865
FDA-2012-N-0477-0011,FDA,FDA-2012-N-0477,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,,2019-12-31T14:55:36Z,2019-28249,0,0,090000648425d86a
FDA-2016-D-2565-0018,FDA,FDA-2016-D-2565,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,,2019-12-31T14:56:03Z,2019-28249,0,0,090000648425d8ae
FDA-2016-N-4319-0004,FDA,FDA-2016-N-4319,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Unique Device Identification System,Notice,General Notice,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,2020-01-31T04:59:59Z,2020-01-20T02:01:08Z,2019-28246,0,0,090000648425d412
FDA-2019-N-0305-0005,FDA,FDA-2019-N-0305,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,,2022-10-14T13:05:41Z,2019-28249,0,0,090000648425d867
FDA-2019-D-5743-0003,FDA,FDA-2019-D-5743,"Importation of Certain Food and Drug Administration-Approved Human
Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for
Industry; Availability; Correction",Notice,Correction,2019-12-30T05:00:00Z,2019,12,2019-12-30T05:00:00Z,2020-02-22T04:59:59Z,2020-02-22T02:01:09Z,2019-28141,0,0,0900006484256d94
FDA-2013-N-0804-0007,FDA,FDA-2013-N-0804,Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification,Notice,60 Day Proposed Information Collection,2019-12-30T05:00:00Z,2019,12,2019-12-30T05:00:00Z,2020-02-29T04:59:59Z,2019-12-30T15:11:07Z,2019-28098,0,0,0900006484256f92
FDA-2019-D-5364-0001,FDA,FDA-2019-D-5364,Submission of Plans for Cigarette Packages and Cigarette Advertisements; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2019-12-30T05:00:00Z,2019,12,2019-12-30T05:00:00Z,2020-01-30T04:59:59Z,2020-01-30T02:03:13Z,2019-27991,0,0,0900006484256cad
FDA-2018-N-2434-0003,FDA,FDA-2018-N-2434,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Formal Meetings
Between the Food and Drug Administration and Sponsors and Applicants of Prescription Drug User Fee Act Products",Notice,30 Day Proposed Information Collection,2019-12-27T05:00:00Z,2019,12,2019-12-27T05:00:00Z,2020-01-28T04:59:59Z,2019-12-27T15:31:52Z,2019-27835,0,0,090000648425244e
FDA-2019-N-0001-0009,FDA,FDA-2019-N-0001,The Tobacco Products Scientific Advisory Committee; Notice of Meeting,Notice,Meeting,2019-12-26T05:00:00Z,2019,12,2019-12-26T05:00:00Z,,2019-12-26T14:49:56Z,2019-27774,0,0,090000648424fff4
FDA-2013-N-0579-0009,FDA,FDA-2013-N-0579,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Biological
Products: Reporting of Biological Product Deviations and Human Cells,
Tissues, and Cellular and Tissue-Based Deviations in Manufacturing",Notice,30 Day Proposed Information Collection,2019-12-26T05:00:00Z,2019,12,2019-12-26T05:00:00Z,2020-01-28T04:59:59Z,2019-12-26T15:03:34Z,2019-27791,0,0,090000648424ffef
FDA-2019-D-4739-0001,FDA,FDA-2019-D-4739,Requesting Food and Drug Administration Feedback on Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2019-12-26T05:00:00Z,2019,12,2019-12-26T05:00:00Z,2020-02-25T04:59:59Z,2020-02-25T02:01:52Z,2019-27799,0,0,090000648424ff26
FDA-2019-D-5743-0001,FDA,FDA-2019-D-5743,"Importation of Certain Food and Drug Administration-Approved Human
Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for
Industry; Availability",Notice,Notice of Availability,2019-12-23T05:00:00Z,2019,12,2019-12-23T05:00:00Z,2020-02-22T04:59:59Z,2020-02-22T02:00:34Z,2019-27475,0,0,0900006484248282
FDA-2018-D-3759-0011,FDA,FDA-2018-D-3759,Considerations for the Development of Dried Plasma Products Intended for Transfusion; Guidance for Industry; Availability,Notice,Notice of Availability,2019-12-20T05:00:00Z,2019,12,2019-12-20T05:00:00Z,,2019-12-20T13:50:21Z,2019-27520,0,0,090000648423ff4d
FDA-2019-D-4964-0001,FDA,FDA-2019-D-4964,Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2019-12-20T05:00:00Z,2019,12,2019-12-20T05:00:00Z,2020-02-19T04:59:59Z,2020-02-23T17:58:48Z,2019-27524,0,0,090000648423ffd2
FDA-2013-N-0403-0008,FDA,FDA-2013-N-0403,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Protection of Human Subjects; Informed Consent; and Institutional Review Boards",Notice,30 Day Proposed Information Collection,2019-12-19T05:00:00Z,2019,12,2019-12-19T05:00:00Z,2020-01-22T04:59:59Z,2019-12-19T14:57:36Z,2019-27351,0,0,0900006484235d08
FDA-2019-D-5585-0001,FDA,FDA-2019-D-5585,Bridging for Drug-Device and Biologic- Device Combination Products; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2019-12-19T05:00:00Z,2019,12,2019-12-19T05:00:00Z,2020-02-19T04:59:59Z,2020-02-21T13:51:04Z,2019-27354,0,0,0900006484235c2e
FDA-2010-D-0529-0023,FDA,FDA-2010-D-0529,"Qualification Process for Drug Development Tools; Draft Guidance for
Industry; Availability",Notice,Notice of Availability,2019-12-16T05:00:00Z,2019,12,2019-12-16T05:00:00Z,2020-02-15T04:59:59Z,2020-02-15T02:02:17Z,2019-26994,0,0,0900006484212725
FDA-2007-D-0369-0478,FDA,FDA-2007-D-0369,Product-Specific Guidance for Cocaine Hydrochloride; Nasal Solution; New Draft Guidance for Industry; Availability,Notice,Notice of Availability,2019-12-16T05:00:00Z,2019,12,2019-12-16T05:00:00Z,2020-02-15T04:59:59Z,2020-02-13T03:46:02Z,2019-26971,0,0,0900006484212850
FDA-2018-N-1262-0008,FDA,FDA-2018-N-1262,"Notice of Approval of Product Under Voucher: Rare Pediatric Disease
Priority Review Voucher",Notice,Notice of Approval,2019-12-16T05:00:00Z,2019,12,2019-12-16T05:00:00Z,,2019-12-16T15:12:52Z,2019-27054,0,0,0900006484212720
FDA-2019-N-0001-0008,FDA,FDA-2019-N-0001,"Statement of Organization, Functions, and Delegations of Authority",Notice,General Notice,2019-12-16T05:00:00Z,2019,12,2019-12-16T05:00:00Z,,2019-12-16T18:09:47Z,2019-26952,0,0,090000648421284e
FDA-2019-N-3077-0004,FDA,FDA-2019-N-3077,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities,Notice,30 Day Proposed Information Collection,2019-12-16T05:00:00Z,2019,12,2019-12-16T05:00:00Z,2020-01-16T04:59:59Z,2020-01-16T02:02:46Z,2019-27053,0,0,090000648421280b
FDA-2019-D-4751-0001,FDA,FDA-2019-D-4751,Food and Drug Administration Reauthorization Act Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2019-12-13T05:00:00Z,2019,12,2019-12-13T05:00:00Z,2020-02-12T04:59:59Z,2020-05-06T20:45:01Z,2019-26877,0,0,090000648420c58d
FDA-2016-E-2528-0007,FDA,FDA-2016-E-2528,"Determination of Regulatory Review Period for Purposes of Patent
Extension; BRIVIACT ORAL TABLETS, New Drug Application 205836",Notice,Determinations,2019-12-12T05:00:00Z,2019,12,2019-12-12T05:00:00Z,2020-02-11T04:59:59Z,2019-12-12T14:29:37Z,2019-26813,0,0,0900006484206ad6
FDA-2018-N-0417-0002,FDA,FDA-2018-N-0417,Request for Nominations on the National Mammography Quality Assurance Advisory Committee,Notice,Request for Nominations,2019-12-12T05:00:00Z,2019,12,2019-12-12T05:00:00Z,,2019-12-12T14:33:45Z,2019-26735,0,0,0900006484206b20
FDA-2016-E-2529-0008,FDA,FDA-2016-E-2529,"Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT ORAL SOLUTION, New Drug Application 205838",Notice,Determinations,2019-12-12T05:00:00Z,2019,12,2019-12-12T05:00:00Z,2020-02-11T04:59:59Z,2019-12-12T14:38:30Z,2019-26814,0,0,0900006484206b7a
FDA-2016-E-2525-0006,FDA,FDA-2016-E-2525,Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT INJECTION New Drug Application 205837,Notice,Determinations,2019-12-12T05:00:00Z,2019,12,2019-12-12T05:00:00Z,2020-02-11T04:59:59Z,2020-01-28T02:04:02Z,2019-26812,0,0,0900006484206a35
FDA-2016-N-2474-0005,FDA,FDA-2016-N-2474,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Reporting
Associated With Designated New Animal Drugs for Minor Use and Minor
Speciess",Notice,30 Day Proposed Information Collection,2019-12-11T05:00:00Z,2019,12,2019-12-11T05:00:00Z,2020-01-11T04:59:59Z,2023-06-02T20:19:47Z,2019-26682,0,0,0900006484200c94
FDA-2018-E-2617-0003,FDA,FDA-2018-E-2617,"Determination of Regulatory Review Period for Purposes of Patent
Extension; VABOMERE",Notice,Determinations,2019-12-11T05:00:00Z,2019,12,2019-12-11T05:00:00Z,2020-02-11T04:59:59Z,2019-12-12T14:42:41Z,2019-26655,0,0,0900006484200d32
FDA-2019-D-4433-0001,FDA,FDA-2019-D-4433,Development of Locally Applied Corticosteroid Products for the Short- Term Treatment of Symptoms Associated With Internal or External Hemorrhoids; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2019-12-09T05:00:00Z,2019,12,2019-12-09T05:00:00Z,2020-02-08T04:59:59Z,2020-02-08T02:03:51Z,2019-26464,0,0,09000064841f6201
FDA-2019-D-1650-0001,FDA,FDA-2019-D-1650,Magnetic Resonance Coil— Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2019-12-09T05:00:00Z,2019,12,2019-12-09T05:00:00Z,2020-02-08T04:59:59Z,2020-02-08T02:02:12Z,2019-26470,0,0,09000064841f62ee
FDA-2019-E-1079-0005,FDA,FDA-2019-E-1079,Determination of Regulatory Review Period for Purposes of Patent Extension: PALYNZIQ,Notice,Determinations,2019-12-06T05:00:00Z,2019,12,2019-12-06T05:00:00Z,2020-06-04T03:59:59Z,2019-12-06T14:26:16Z,2019-26327,0,0,09000064841ed900
FDA-2019-N-5611-0001,FDA,FDA-2019-N-5611,Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments,Notice,Meeting,2019-12-06T05:00:00Z,2019,12,2019-12-06T05:00:00Z,2020-01-15T04:59:59Z,2020-01-15T02:03:43Z,2019-26377,0,0,09000064841ed518
FDA-2019-N-5552-0001,FDA,FDA-2019-N-5552,Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request  for Comments,Notice,Meeting,2019-12-06T05:00:00Z,2019,12,2019-12-06T05:00:00Z,2020-01-14T04:59:59Z,2020-01-15T02:03:05Z,2019-26338,0,0,09000064841ecfa8
FDA-2019-E-1076-0005,FDA,FDA-2019-E-1076,Determination of Regulatory Review Period for Purposes of Patent Extension: PALYNZIQ,Notice,Determinations,2019-12-06T05:00:00Z,2019,12,2019-12-06T05:00:00Z,2020-06-04T03:59:59Z,2019-12-06T14:19:08Z,2019-26327,0,0,09000064841ed563
FDA-2013-N-0731-0009,FDA,FDA-2013-N-0731,"Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice",Notice,60 Day Proposed Information Collection,2019-12-05T05:00:00Z,2019,12,2019-12-05T05:00:00Z,2020-02-04T04:59:59Z,2019-12-05T16:16:42Z,2019-26234,0,0,09000064841e74ee
FDA-2019-E-1061-0004,FDA,FDA-2019-E-1061,Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEXXA,Notice,Determinations,2019-12-05T05:00:00Z,2019,12,2019-12-05T05:00:00Z,2020-06-03T03:59:59Z,2019-12-05T16:00:10Z,2019-26251,0,0,09000064841e85d8
FDA-2019-E-1060-0005,FDA,FDA-2019-E-1060,Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEXXA,Notice,Determinations,2019-12-05T05:00:00Z,2019,12,2019-12-05T05:00:00Z,2020-06-03T03:59:59Z,2019-12-05T15:58:19Z,2019-26251,0,0,09000064841e85d7
FDA-2018-E-2596-0004,FDA,FDA-2018-E-2596,Determination of Regulatory Review Period for Purposes of Patent Extension; LUXTURNA,Notice,Determinations,2019-12-05T05:00:00Z,2019,12,2019-12-05T05:00:00Z,2020-06-03T03:59:59Z,2019-12-05T14:47:45Z,2019-26252,0,0,09000064841e7408
FDA-2018-N-3179-0002,FDA,FDA-2018-N-3179,Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee,Notice,Advisory Committee,2019-12-05T05:00:00Z,2019,12,2019-12-05T05:00:00Z,2020-01-07T04:59:59Z,2020-01-07T02:01:26Z,2019-26276,0,0,09000064841e7410
FDA-2019-N-5464-0001,FDA,FDA-2019-N-5464,Novel Excipient Review Program Proposal; Request for Information and Comments,Notice,60 Day Proposed Information Collection,2019-12-05T05:00:00Z,2019,12,2019-12-05T05:00:00Z,2020-02-04T04:59:59Z,2020-02-04T02:01:22Z,2019-26266,0,0,09000064841e74ea
FDA-2019-D-4656-0001,FDA,FDA-2019-D-4656,Interstitial Cystitis/Bladder Pain Syndrome: Establishing Effectiveness of Drugs for Treatment; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2019-12-05T05:00:00Z,2019,12,2019-12-05T05:00:00Z,2020-02-04T04:59:59Z,2020-02-04T02:03:52Z,2019-26264,0,0,09000064841e7409
FDA-2013-N-1619-0013,FDA,FDA-2013-N-1619,"Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements",Notice,60 Day Proposed Information Collection,2019-12-05T05:00:00Z,2019,12,2019-12-05T05:00:00Z,2020-02-04T04:59:59Z,2023-04-10T19:29:26Z,2019-26250,0,0,09000064841e74e6
FDA-2018-N-3207-0002,FDA,FDA-2018-N-3207,Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee,Notice,Request for Nominations,2019-12-05T05:00:00Z,2019,12,2019-12-05T05:00:00Z,2020-02-04T04:59:59Z,2019-12-05T15:42:10Z,2019-26279,0,0,09000064841e7452
FDA-2019-E-1059-0004,FDA,FDA-2019-E-1059,Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEXXA,Notice,Determinations,2019-12-05T05:00:00Z,2019,12,2019-12-05T05:00:00Z,2020-06-03T03:59:59Z,2019-12-05T15:56:38Z,2019-26251,0,0,09000064841e7454
FDA-2019-N-5119-0001,FDA,FDA-2019-N-5119,Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments,Notice,Request for Comments,2019-12-04T05:00:00Z,2019,12,2019-12-04T05:00:00Z,2019-12-17T04:59:59Z,2019-12-17T02:04:01Z,2019-26222,0,0,09000064841e25a1
FDA-2018-E-4403-0005,FDA,FDA-2018-E-4403,"Determination of Regulatory Review Period for Purposes of Patent
Extension; AIMOVIG",Notice,Determinations,2019-12-03T05:00:00Z,2019,12,2019-12-03T05:00:00Z,2020-02-04T04:59:59Z,2020-02-03T02:00:48Z,2019-26081,0,0,09000064841dda28
FDA-2019-N-5120-0001,FDA,FDA-2019-N-5120,Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments,Notice,Meeting,2019-12-03T05:00:00Z,2019,12,2019-12-03T05:00:00Z,2019-12-18T04:59:59Z,2019-12-18T02:01:19Z,2019-26143,0,0,09000064841ddac9
FDA-2019-N-4590-0001,FDA,FDA-2019-N-4590,"Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 21
Abbreviated New Drug Applications",Notice,Withdrawal,2019-12-02T05:00:00Z,2019,12,2019-12-02T05:00:00Z,,2020-05-04T17:35:53Z,2019-25946,0,0,09000064841d66e7
FDA-2018-D-3124-0025,FDA,FDA-2018-D-3124,"Adaptive Designs for Clinical Trials of Drugs and Biologics; Guidance for
Industry; Availability",Notice,Notice of Availability,2019-12-02T05:00:00Z,2019,12,2019-12-02T05:00:00Z,2020-01-03T04:59:59Z,2020-05-04T17:31:30Z,2019-25986,0,0,09000064841d6538
FDA-2016-N-3995-0004,FDA,FDA-2016-N-3995,Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Information on Pediatric Uses of Medical Devices,Notice,60 Day Proposed Information Collection,2019-12-02T05:00:00Z,2019,12,2019-12-02T05:00:00Z,2020-02-01T04:59:59Z,2019-12-04T02:03:29Z,2019-25980,0,0,09000064841d66ea
FDA-2019-N-1537-0002,FDA,FDA-2019-N-1537,James R. Casey: Final Debarment Order,Notice,Statutory Debarment,2019-11-29T05:00:00Z,2019,11,2019-11-29T05:00:00Z,,2019-11-29T19:11:09Z,2019-25848,0,0,09000064841c8e8e
FDA-2019-N-0163-0003,FDA,FDA-2019-N-0163,"Hospira, Inc., et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications",Notice,Withdrawal,2019-11-29T05:00:00Z,2019,11,2019-11-29T05:00:00Z,,2019-11-29T19:16:15Z,2019-25901,0,0,09000064841c88a9
FDA-2019-D-5255-0002,FDA,FDA-2019-D-5255,Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2019-11-29T05:00:00Z,2019,11,2019-11-29T05:00:00Z,2020-01-29T04:59:59Z,2020-01-29T02:08:15Z,2019-25919,0,0,09000064841c88a5
FDA-2019-N-1614-0002,FDA,FDA-2019-N-1614,Tzvi Lexier: Final Debarment Order,Notice,Statutory Debarment,2019-11-29T05:00:00Z,2019,11,2019-11-29T05:00:00Z,,2019-11-29T19:18:11Z,2019-25824,0,0,09000064841c8d3b
FDA-2018-E-2595-0004,FDA,FDA-2018-E-2595,Determination of Regulatory Review Period for Purposes of Patent Extension; OZEMPIC,Notice,Determinations,2019-11-29T05:00:00Z,2019,11,2019-11-29T05:00:00Z,2020-05-28T03:59:59Z,2019-11-29T19:13:51Z,2019-25850,0,0,09000064841c881f
FDA-2018-E-4429-0005,FDA,FDA-2018-E-4429,Determination of Regulatory Review Period for Purposes of Patent Extension; CRYSVITA,Notice,Determinations,2019-11-29T05:00:00Z,2019,11,2019-11-29T05:00:00Z,2020-05-28T03:59:59Z,2020-05-25T01:00:37Z,2019-25821,0,0,09000064841c881c
FDA-2013-N-0879-0008,FDA,FDA-2013-N-0879,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the
Safe and Sanitary Processing and Importing of Fish and Fishery Products",Notice,30 Day Proposed Information Collection,2019-11-29T05:00:00Z,2019,11,2019-11-29T05:00:00Z,2019-12-31T04:59:59Z,2019-11-29T19:17:35Z,2019-25857,0,0,09000064841c8d34
FDA-2019-D-5324-0001,FDA,FDA-2019-D-5324,Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products; Guidance for Industry; Availability,Notice,Notice of Availability,2019-11-26T05:00:00Z,2019,11,2019-11-26T05:00:00Z,,2019-11-26T14:19:02Z,2019-25578,0,0,09000064841b7724
FDA-2019-N-5465-0001,FDA,FDA-2019-N-5465,Center for Devices and Radiological Health Ethylene Oxide Sterilization Master File Pilot Program,Notice,Request for Applications,2019-11-26T05:00:00Z,2019,11,2019-11-26T05:00:00Z,,2019-11-26T14:14:33Z,2019-25631,0,0,09000064841b75be
FDA-2019-D-3592-0001,FDA,FDA-2019-D-3592,"Certificates of Confidentiality; Draft Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2019-11-25T05:00:00Z,2019,11,2019-11-25T05:00:00Z,2020-01-10T04:59:59Z,2020-01-09T02:03:06Z,2019-25551,0,0,09000064841ac63b
FDA-2016-N-2066-0004,FDA,FDA-2016-N-2066,Agency Information Collection Activities; Proposed Collection; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests,Notice,60 Day Proposed Information Collection,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,2020-01-22T04:59:59Z,2019-11-24T02:02:33Z,2019-25364,0,0,0900006484197fea
FDA-2011-N-0776-0014,FDA,FDA-2011-N-0776,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,,2019-11-22T16:48:10Z,2019-07467,0,0,0900006483bad8bb
FDA-2007-D-0369-0476,FDA,FDA-2007-D-0369,Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability,Notice,Notice of Availability,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,2020-01-22T04:59:59Z,2020-02-28T02:02:42Z,2019-25326,0,0,0900006484197f8c
FDA-2012-N-0129-0014,FDA,FDA-2012-N-0129,Agency Information Collection Activities; Proposed Additional Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications; Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants,Notice,60 Day Proposed Information Collection,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,2020-01-22T04:59:59Z,2019-11-22T14:28:29Z,2019-25328,0,0,0900006484197e92
FDA-2019-N-4844-0001,FDA,FDA-2019-N-4844,"‘‘Ruby Chocolate’’ Deviating From Identity Standard; Temporary Permit
for Market Testing",Notice,Notice of Temporary Permit,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,,2019-11-22T16:58:37Z,2019-25325,0,0,0900006484197fe7
FDA-2018-N-2970-0003,FDA,FDA-2018-N-2970,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,,2019-11-22T16:41:39Z,2019-07467,0,0,0900006483bad4cc
FDA-2017-N-1779-0008,FDA,FDA-2017-N-1779,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,,2019-11-22T16:43:14Z,2019-07467,0,0,0900006483bad4cd
FDA-2018-N-3728-0005,FDA,FDA-2018-N-3728,Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Information for Participation in the Food and Drug Administration Non- Employee Fellowship and Traineeship Programs,Notice,60 Day Proposed Information Collection,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,2020-01-22T04:59:59Z,2023-02-14T15:03:49Z,2019-25332,0,0,0900006484197fee
FDA-2009-D-0268-0020,FDA,FDA-2009-D-0268,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,,2019-11-22T16:46:20Z,2019-07467,0,0,0900006483bad8b9
FDA-2010-D-0319-0029,FDA,FDA-2010-D-0319,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dear Health Care Provider Letters: Improving Communication of Important Safety Information,Notice,30 Day Proposed Information Collection,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,2019-12-24T04:59:59Z,2019-12-25T02:01:39Z,2019-25333,0,0,0900006484198033
FDA-2016-N-0736-0005,FDA,FDA-2016-N-0736,"Agency Information Collection Activities; Proposed Collection; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet",Notice,60 Day Proposed Information Collection,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,2020-01-22T04:59:59Z,2019-11-24T02:01:32Z,2019-25327,0,0,0900006484197f45
FDA-2012-N-0129-0015,FDA,FDA-2012-N-0129,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,,2019-11-22T16:45:10Z,2019-07467,0,0,0900006483bad4d0
FDA-2014-D-0609-0030,FDA,FDA-2014-D-0609,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,,2019-11-22T16:47:20Z,2019-07467,0,0,0900006483bad8ba
FDA-2012-N-0197-0006,FDA,FDA-2012-N-0197,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Shortages Data Collection System,Notice,30 Day Proposed Information Collection,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,2019-12-24T04:59:59Z,2019-11-24T02:02:46Z,2019-25368,0,0,0900006484197eec
FDA-2008-N-0500-0010,FDA,FDA-2008-N-0500,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,,2019-11-22T16:44:23Z,2019-07467,0,0,0900006483bad4cf
FDA-2018-N-1967-0003,FDA,FDA-2018-N-1967,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,,2019-11-22T16:40:30Z,2019-07467,0,0,0900006483bad4c7
FDA-2013-N-1147-0007,FDA,FDA-2013-N-1147,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition,Notice,30 Day Proposed Information Collection,2019-11-22T05:00:00Z,2019,11,2019-11-22T05:00:00Z,2019-12-24T04:59:59Z,2022-10-21T19:21:41Z,2019-25370,0,0,0900006484197df6
FDA-2019-D-4447-0001,FDA,FDA-2019-D-4447,"Transdermal and Topical Delivery Systems—Product Development and
Quality Considerations; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2019-11-21T05:00:00Z,2019,11,2019-11-21T05:00:00Z,2020-02-20T04:59:59Z,2020-02-21T02:02:24Z,2019-25246,0,0,090000648418f9ef
FDA-2018-N-3442-0089,FDA,FDA-2018-N-3442,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Web-Based Pilot Survey To Assess Allergy to Cosmetics in the United States,Notice,30 Day Proposed Information Collection,2019-11-21T05:00:00Z,2019,11,2019-11-21T05:00:00Z,2019-12-24T04:59:59Z,2019-11-24T02:01:41Z,2019-25274,0,0,090000648418fb2c
FDA-2019-N-5035-0001,FDA,FDA-2019-N-5035,"Anesthetic and Analgesic Drug Products Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments",Notice,Request for Comments,2019-11-21T05:00:00Z,2019,11,2019-11-21T05:00:00Z,2020-01-16T04:59:59Z,2020-01-15T02:01:35Z,2019-25278,0,0,090000648418fa34
FDA-2019-N-4963-0001,FDA,FDA-2019-N-4963,"Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments",Notice,Request for Comments,2019-11-21T05:00:00Z,2019,11,2019-11-21T05:00:00Z,2019-12-14T04:59:59Z,2019-12-15T02:01:07Z,2019-25247,0,0,090000648418fb7f
FDA-2018-D-4533-0001,FDA,FDA-2018-D-4533,"Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance
for Industry; Availability",Notice,Notice of Availability,2019-11-20T05:00:00Z,2019,11,2019-11-20T05:00:00Z,2020-02-19T04:59:59Z,2020-10-13T19:32:07Z,2019-25139,0,0,090000648418566d
FDA-2018-N-4626-0001,FDA,FDA-2018-N-4626,List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals; Request for Nominations,Notice,Request for Nominations,2019-11-20T05:00:00Z,2019,11,2019-11-20T05:00:00Z,,2026-01-24T11:51:45Z,2019-25140,1,0,090000648418571f
FDA-2019-N-4187-0029,FDA,FDA-2019-N-4187,A New Era of Smarter Food Safety; Extension of Comment Period,Notice,Extension of Comment Period,2019-11-20T05:00:00Z,2019,11,2019-11-20T05:00:00Z,2019-12-06T04:59:59Z,2019-12-13T18:03:12Z,2019-25123,0,0,090000648418571d
FDA-2019-N-5157-0001,FDA,FDA-2019-N-5157,2019 Public Meeting on Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program; Public Meeting; Request for Comments,Notice,Public Meetings,2019-11-20T05:00:00Z,2019,11,2019-11-20T05:00:00Z,2020-03-07T04:59:59Z,2020-03-07T02:02:10Z,2019-25160,0,0,0900006484185668
FDA-2019-N-4693-0001,FDA,FDA-2019-N-4693,"Mayne Pharma Group Limited and Actavis Laboratories UT, Inc.; Withdrawal of Approval of Abbreviated New Drug Applications for Fentanyl Transdermal Systems",Notice,Withdrawal,2019-11-18T05:00:00Z,2019,11,2019-11-18T05:00:00Z,,2019-11-18T14:23:03Z,2019-24922,0,0,09000064841714e0
FDA-2019-N-4992-0001,FDA,FDA-2019-N-4992,"Pan American Laboratories, LLC, et al.; Proposal To Withdraw Approval of Four New Drug Applications; Opportunity for a Hearing",Notice,Notice of Opportunity of Hearing,2019-11-18T05:00:00Z,2019,11,2019-11-18T05:00:00Z,2020-01-18T04:59:59Z,2019-11-18T14:18:41Z,2019-24921,0,0,09000064841714db
FDA-2018-D-1835-0009,FDA,FDA-2018-D-1835,Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention; Guidance for Industry; Availability,Notice,Notice of Availability,2019-11-18T05:00:00Z,2019,11,2019-11-18T05:00:00Z,,2019-11-18T14:07:39Z,2019-24916,0,0,09000064841713b7
FDA-2019-N-2649-0001,FDA,FDA-2019-N-2649,"Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal",Notice,Notice of Renewal,2019-11-18T05:00:00Z,2019,11,2019-11-18T05:00:00Z,,2019-11-18T14:14:57Z,2019-24917,0,0,0900006484171498
FDA-2016-N-2544-0005,FDA,FDA-2016-N-2544,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Current Good Manufacturing Practice Quality System Regulation,Notice,30 Day Proposed Information Collection,2019-11-15T05:00:00Z,2019,11,2019-11-15T05:00:00Z,2019-12-17T04:59:59Z,2019-11-21T02:03:45Z,2019-24805,0,0,0900006484161302