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

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

799 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2019 sorted by posted_date descending

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posted_year 1

  • 2019 · 799 ✖

document_type 1

  • Notice · 799 ✖

agency_id 1

  • FDA · 799 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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and GLUCOPHAGE XR (Metformin Hydrochloride) Oral Extended-Release Tablets, 500 Milligrams and 750 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2019-12-31T05:00:00Z 2019 12 2019-12-31T05:00:00Z   2019-12-31T14:31:28Z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

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