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withdrawn,object_id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-2022-N-2375-0003,FDA,FDA-2022-N-2375,Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability,Notice,Announcement,2022-12-30T05:00:00Z,2022,12,2022-12-30T05:00:00Z,,2022-12-30T16:46:00Z,2022-28460,0,0,0900006485564bf9
FDA-2022-D-3054-0001,FDA,FDA-2022-D-3054,M11 Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Guidance for Industry; Draft Template; and Technical Specification; Availability,Notice,Notice of Availability,2022-12-22T05:00:00Z,2022,12,,,2022-12-22T14:20:38Z,2022-27832,0,0,090000648554d5cb
FDA-2017-D-0085-0044,FDA,FDA-2017-D-0085,Best Practices for Convening a GRAS Panel; Guidance for Industry; Availability,Notice,Notice of Availability,2022-12-22T05:00:00Z,2022,12,2022-12-22T05:00:00Z,,2022-12-22T14:39:30Z,2022-27714,0,0,090000648554882e
FDA-2022-N-3129-0001,FDA,FDA-2022-N-3129,Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments,Notice,Request for Comments,2022-12-22T05:00:00Z,2022,12,2022-12-22T05:00:00Z,2023-02-09T04:59:59Z,2022-12-22T13:43:29Z,2022-27834,0,0,090000648554d4a4
FDA-2014-D-1167-0024,FDA,FDA-2014-D-1167,Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2022-12-22T05:00:00Z,2022,12,,,2022-12-22T13:50:27Z,2022-27827,0,0,090000648554d546
FDA-2016-N-0736-0009,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,2022-12-22T05:00:00Z,2022,12,2022-12-22T05:00:00Z,2023-02-22T04:59:59Z,2022-12-24T02:00:59Z,2022-27825,0,0,090000648554d5c4
FDA-2012-D-0530-0038,FDA,FDA-2012-D-0530,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Q-Submission Program for Medical Devices,Notice,30 Day Proposed Information Collection,2022-12-22T05:00:00Z,2022,12,2022-12-22T05:00:00Z,2023-01-24T04:59:59Z,2022-12-22T14:51:41Z,2022-27815,0,0,090000648554d616
FDA-2018-N-0417-0007,FDA,FDA-2018-N-0417,Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee,Notice,Request for Nominations,2022-12-22T05:00:00Z,2022,12,,,2022-12-22T13:25:37Z,2022-27883,0,0,090000648554cc75
FDA-2022-N-3208-0001,FDA,FDA-2022-N-3208,Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports,Notice,60 Day Proposed Information Collection,2022-12-22T05:00:00Z,2022,12,2022-12-22T05:00:00Z,2023-02-22T04:59:59Z,2022-12-24T02:01:01Z,2022-27817,0,0,090000648554d3b5
FDA-2020-D-1140-0013,FDA,FDA-2020-D-1140,Enforcement Policy Regarding Federal Veterinarian-Client-Patient Relationship Requirements To Facilitate Veterinary Telemedicine During the COVID–19 Outbreak; Withdrawal of Guidance,Notice,Withdrawal,2022-12-21T05:00:00Z,2022,12,2022-12-21T05:00:00Z,,2022-12-21T20:38:42Z,2022-27673,0,0,09000064855488d5
FDA-2012-P-1189-0016,FDA,FDA-2012-P-1189,"Canned Tuna Deviating From Identity Standard; Amendment of Temporary
Marketing Permit",Notice,General Notice,2022-12-21T05:00:00Z,2022,12,2022-12-21T05:00:00Z,,2022-12-21T20:41:10Z,2022-27710,0,0,0900006485548da1
FDA-2022-P-0614-0006,FDA,FDA-2022-P-0614,"Determination That ZYBAN (Bupropion Hydrochloride) Tablets, Extended
Release, 150 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2022-12-21T05:00:00Z,2022,12,2022-12-21T05:00:00Z,,2022-12-21T15:58:45Z,2022-27647,0,0,0900006485548d58
FDA-2022-N-2810-0001,FDA,FDA-2022-N-2810,Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments,Notice,Meeting,2022-12-19T05:00:00Z,2022,12,2022-12-19T05:00:00Z,2023-01-26T04:59:59Z,2023-01-27T02:00:46Z,2022-27428,0,0,09000064855400fc
FDA-1998-D-0038-0007,FDA,FDA-1998-D-0038,Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern; Revised Draft Guidance for Industry; Availability,Notice,Notice of Availability,2022-12-19T05:00:00Z,2022,12,2022-12-19T05:00:00Z,,2022-12-19T13:50:31Z,2022-27415,0,0,0900006485540064
FDA-2020-N-1206-0004,FDA,FDA-2020-N-1206,Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.7 Implementation Guide 3.3 and for Define-Extensible Markup Language Version 2.1; Requirement Ends for Study Data Tabulation Model Version 1.3 Implementation Guide 3.1.3; Correction,Notice,Correction,2022-12-16T05:00:00Z,2022,12,2022-12-16T05:00:00Z,,2022-12-16T14:13:59Z,2022-27346,0,0,090000648553ca8d
FDA-2013-D-0710-0018,FDA,FDA-2013-D-0710,"Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection; Draft Guidance for Industry, Revision 1; Availability",Notice,Notice of Availability,2022-12-16T05:00:00Z,2022,12,,,2022-12-16T17:50:05Z,2022-27344,0,0,090000648553cabe
FDA-2013-D-1319-0009,FDA,FDA-2013-D-1319,Pulmonary Tuberculosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2022-12-15T05:00:00Z,2022,12,,,2022-12-15T15:05:52Z,2022-27186,0,0,090000648553845d
FDA-2021-N-0555-1173,FDA,FDA-2021-N-0555,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,General Notice,2022-12-15T05:00:00Z,2022,12,2022-12-15T05:00:00Z,,2022-12-15T21:57:11Z,2022-27192,0,0,0900006485534831
FDA-2012-N-0386-0019,FDA,FDA-2012-N-0386,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,General Notice,2022-12-15T05:00:00Z,2022,12,2022-12-15T05:00:00Z,,2022-12-15T21:47:53Z,2022-27192,0,0,0900006485534369
FDA-2019-N-0430-0009,FDA,FDA-2019-N-0430,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,General Notice,2022-12-15T05:00:00Z,2022,12,2022-12-15T05:00:00Z,,2022-12-15T21:51:35Z,2022-27192,0,0,090000648553436a
FDA-2019-N-5553-0027,FDA,FDA-2019-N-5553,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,General Notice,2022-12-15T05:00:00Z,2022,12,2022-12-15T05:00:00Z,,2022-12-15T21:55:28Z,2022-27192,0,0,0900006485538a84
FDA-2014-N-1048-0013,FDA,FDA-2014-N-1048,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,General Notice,2022-12-15T05:00:00Z,2022,12,2022-12-15T05:00:00Z,,2022-12-15T14:39:32Z,2022-27192,0,0,0900006485538415
FDA-2018-N-3728-0012,FDA,FDA-2018-N-3728,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Collection of Conflict-of-Interest Information for Participation in Food and Drug Administration Non-Employee
Fellowship and Traineeship Programs",Notice,30 Day Proposed Information Collection,2022-12-15T05:00:00Z,2022,12,2022-12-15T05:00:00Z,2023-01-18T04:59:59Z,2023-02-14T15:07:07Z,2022-27194,0,0,09000064855383d6
FDA-2019-N-1517-0009,FDA,FDA-2019-N-1517,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,General Notice,2022-12-15T05:00:00Z,2022,12,2022-12-15T05:00:00Z,,2022-12-15T22:04:23Z,2022-27192,0,0,0900006485538ab6
FDA-2021-N-1050-0019,FDA,FDA-2021-N-1050,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; Targeted Mechanism of Action Presentations in Prescription Drug Promotion",Notice,Notice of Approval,2022-12-14T05:00:00Z,2022,12,2022-12-14T05:00:00Z,,2022-12-14T14:26:43Z,2022-27140,0,0,090000648553621c
FDA-2022-N-2969-0001,FDA,FDA-2022-N-2969,Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal,Notice,Announcement,2022-12-14T05:00:00Z,2022,12,2022-12-14T05:00:00Z,,2022-12-14T15:11:12Z,2022-27022,0,0,090000648553630a
FDA-2022-N-0521-0002,FDA,FDA-2022-N-0521,David J. Kempema: Final Debarment Order,Notice,General Notice,2022-12-14T05:00:00Z,2022,12,2022-12-14T05:00:00Z,,2022-12-14T14:15:33Z,2022-27091,0,0,09000064855361d1
FDA-2018-N-1262-0017,FDA,FDA-2018-N-1262,Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher,Notice,Notice of Approval,2022-12-14T05:00:00Z,2022,12,2022-12-14T05:00:00Z,,2022-12-14T14:00:50Z,2022-27138,0,0,0900006485535ce4
FDA-2016-N-2544-0013,FDA,FDA-2016-N-2544,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quality System Regulation,Notice,30 Day Proposed Information Collection,2022-12-13T05:00:00Z,2022,12,2022-12-13T05:00:00Z,2023-01-13T04:59:59Z,2022-12-13T16:33:19Z,2022-27023,0,0,0900006485532492
FDA-2018-N-3091-0003,FDA,FDA-2018-N-3091,Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal,Notice,Notice of Renewal,2022-12-13T05:00:00Z,2022,12,2022-12-13T05:00:00Z,,2022-12-13T16:40:16Z,2022-27014,0,0,0900006485532499
FDA-2012-N-0977-0018,FDA,FDA-2012-N-0977,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents,Notice,30 Day Proposed Information Collection,2022-12-13T05:00:00Z,2022,12,2022-12-13T05:00:00Z,2023-01-13T04:59:59Z,2022-12-14T14:28:52Z,2022-27011,0,0,0900006485532496
FDA-2010-D-0319-0036,FDA,FDA-2010-D-0319,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dear Healthcare Provider Letters: Improving Communication of Important Safety Information,Notice,30 Day Proposed Information Collection,2022-12-13T05:00:00Z,2022,12,2022-12-13T05:00:00Z,2023-01-13T04:59:59Z,2022-12-13T16:37:39Z,2022-27012,0,0,09000064855324d8
FDA-2022-N-1794-0011,FDA,FDA-2022-N-1794,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Drug Labeling Provisions and Over-the-Counter Monograph Drug User Fee Submissions,Notice,30 Day Proposed Information Collection,2022-12-13T05:00:00Z,2022,12,2022-12-13T05:00:00Z,2023-01-13T04:59:59Z,2022-12-13T16:35:12Z,2022-27016,0,0,0900006485532493
FDA-2022-D-2873-0001,FDA,FDA-2022-D-2873,Voluntary Malfunction Summary Reporting Program for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2022-12-09T05:00:00Z,2022,12,2022-12-09T05:00:00Z,2023-02-08T04:59:59Z,2023-02-08T02:00:44Z,2022-26729,0,0,090000648552a72e
FDA-2015-D-4599-0007,FDA,FDA-2015-D-4599,"Content of Human Factors Information in Medical Device Marketing Submissions; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability",Notice,Notice of Availability,2022-12-09T05:00:00Z,2022,12,2022-12-09T05:00:00Z,2023-03-10T04:59:59Z,2023-03-11T02:01:16Z,2022-26767,0,0,090000648552a6ed
FDA-2000-D-0187-0044,FDA,FDA-2000-D-0187,"Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria;
Guidance for Industry; Availability",Notice,Notice of Availability,2022-12-08T05:00:00Z,2022,12,2022-12-08T05:00:00Z,,2022-12-08T15:46:19Z,2022-26711,0,0,0900006485524919
FDA-2022-N-3012-0001,FDA,FDA-2022-N-3012,"Teva Branded Pharmaceutical Products R and D, Inc., et al.; Withdrawal of Approval of 35 New Drug Applications",Notice,Withdrawal,2022-12-08T05:00:00Z,2022,12,2022-12-08T05:00:00Z,,2022-12-08T15:58:52Z,2022-26661,0,0,0900006485524e02
FDA-2022-P-0585-0004,FDA,FDA-2022-P-0585,"Determination That NORFLEX (Orphenadrine Citrate) Injection, 30 Milligrams/Milliliter, and NORFLEX (Orphenadrine Citrate) Extended-
Release Tablet, 100 Milligrams, Were Not Withdrawn From Sale for Reasons
of Safety or Effectiveness",Notice,Determinations,2022-12-08T05:00:00Z,2022,12,2022-12-08T05:00:00Z,,2022-12-08T16:06:44Z,2022-26663,0,0,0900006485524ea2
FDA-2017-D-6580-48870,FDA,FDA-2017-D-6580,Homeopathic Drug Products; Guidance for Food and Drug Administration Staff and Industry; Availability - Final Guidance,Notice,Notice of Availability,2022-12-07T05:00:00Z,2022,12,2022-12-07T05:00:00Z,,2022-12-07T15:57:13Z,2022-26567,0,0,09000064855212ae
FDA-2018-N-1262-0016,FDA,FDA-2018-N-1262,Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher,Notice,Notice of Approval,2022-12-07T05:00:00Z,2022,12,2022-12-07T05:00:00Z,,2022-12-07T16:17:58Z,2022-26565,0,0,09000064855212b5
FDA-2022-D-2301-0001,FDA,FDA-2022-D-2301,Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2022-12-07T05:00:00Z,2022,12,2022-12-07T05:00:00Z,,2022-12-07T16:22:42Z,2022-26564,0,0,0900006485521335
FDA-2021-D-0691-0013,FDA,FDA-2021-D-0691,Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 or Programmed Cell Death-Ligand 1 Blocking Antibodies for Treatment of Patients With Cancer; Guidance for Industry; Availability,Notice,Notice of Availability,2022-12-06T05:00:00Z,2022,12,2022-12-06T05:00:00Z,,2022-12-06T13:06:58Z,2022-26464,0,0,090000648551cdc8
FDA-2019-D-1828-0008,FDA,FDA-2019-D-1828,E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials; International Council for Harmonisation; Guidance for Industry; Availability,Notice,Notice of Availability,2022-12-06T05:00:00Z,2022,12,2022-12-06T05:00:00Z,,2022-12-06T13:19:55Z,2022-26433,0,0,090000648551e24f
FDA-2018-N-3236-0002,FDA,FDA-2018-N-3236,Advisory Committee; Oncologic Drugs Advisory Committee; Renewal,Notice,Notice of Renewal,2022-12-05T05:00:00Z,2022,12,2022-12-05T05:00:00Z,,2022-12-05T13:26:51Z,2022-26363,0,0,09000064855195b3
FDA-2017-D-3101-0017,FDA,FDA-2017-D-3101,Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2022-12-05T05:00:00Z,2022,12,2022-12-05T05:00:00Z,,2022-12-05T13:29:25Z,2022-26412,0,0,09000064855196fa
FDA-2001-D-0197-0002,FDA,FDA-2001-D-0197,"Statistical Approaches To Establishing Bioequivalence; Draft Guidance for
Industry; Availability",Notice,Notice of Availability,2022-12-05T05:00:00Z,2022,12,2022-12-05T05:00:00Z,,2022-12-05T13:39:43Z,2022-26414,0,0,09000064855195b1
FDA-2022-Z-0025-0003,FDA,FDA-2022-Z-0025,"Statement of Organization, Functions,
and Delegations of Authority",Notice,General Notice,2022-12-02T05:00:00Z,2022,12,2022-12-02T05:00:00Z,,2022-12-02T14:54:14Z,2022-26280,0,0,0900006485511aa6
FDA-2022-N-3072-0001,FDA,FDA-2022-N-3072,Virtual Public Meeting: FDA Rare Disease Day 2023 Information,Notice,Meeting,2022-12-02T05:00:00Z,2022,12,2022-12-02T05:00:00Z,2023-04-08T03:59:59Z,2023-04-08T01:01:40Z,,0,0,0900006485513275
FDA-2018-N-3233-0005,FDA,FDA-2018-N-3233,Requests for Nominations: Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee,Notice,Request for Nominations,2022-12-01T05:00:00Z,2022,12,2022-12-01T05:00:00Z,,2022-12-01T13:20:08Z,2022-26125,0,0,090000648550e731
FDA-2022-D-2899-0001,FDA,FDA-2022-D-2899,Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2022-11-30T05:00:00Z,2022,11,2022-11-30T05:00:00Z,,2022-11-30T16:17:29Z,2022-26059,0,0,090000648550a1ef
FDA-2022-D-0099-0001,FDA,FDA-2022-D-0099,"Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry; Availability",Notice,Notice of Availability,2022-11-30T05:00:00Z,2022,11,2022-11-30T05:00:00Z,,2022-11-30T16:52:53Z,2022-26110,0,0,090000648550a242
FDA-2022-N-2855-0001,FDA,FDA-2022-N-2855,"Mylan Institutional, Inc.; Withdrawal of Approval of a New Drug Application for SULFAMYLON® (Mafenide Acetate, USP) Powder for 5% Topical Solution",Notice,Withdrawal,2022-11-30T05:00:00Z,2022,11,2022-11-30T05:00:00Z,,2022-11-30T14:46:10Z,2022-26057,0,0,090000648550a1ec
FDA-2013-D-0811-0153,FDA,FDA-2013-D-0811,Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridioides difficile Infection Not Responsive to Standard Therapies; Guidance for Industry; Availability,Notice,Notice of Availability,2022-11-29T05:00:00Z,2022,11,2022-11-29T05:00:00Z,,2022-11-29T15:13:37Z,2022-26000,0,0,0900006485507229
FDA-2022-N-1129-0003,FDA,FDA-2022-N-1129,Jennings Ryan Staley: Final Debarment Order,Notice,Statutory Debarment,2022-11-29T05:00:00Z,2022,11,2022-11-29T05:00:00Z,,2024-11-12T23:47:21Z,2022-26012,1,0,0900006485507afb
FDA-2019-N-3926-0006,FDA,FDA-2019-N-3926,Request for Nominations for Voting Members on Public Advisory Panels of the Medical Devices Advisory Committee,Notice,Request for Nominations,2022-11-28T05:00:00Z,2022,11,2022-11-28T05:00:00Z,,2022-11-28T16:40:21Z,2022-25813,0,0,0900006485504549
FDA-2022-N-2782-0001,FDA,FDA-2022-N-2782,Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments,Notice,Request for Comments,2022-11-25T05:00:00Z,2022,11,2022-11-25T05:00:00Z,2023-01-24T04:59:59Z,2023-01-04T02:00:57Z,2022-25643,0,0,0900006485500677
FDA-2018-N-1262-0015,FDA,FDA-2018-N-1262,Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher,Notice,Notice of Approval,2022-11-25T05:00:00Z,2022,11,2022-11-25T05:00:00Z,,2022-11-25T14:45:36Z,2022-25644,0,0,0900006485500679
FDA-2022-N-2825-0001,FDA,FDA-2022-N-2825,Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments,Notice,Request for Comments,2022-11-25T05:00:00Z,2022,11,2022-11-25T05:00:00Z,2023-01-07T04:59:59Z,2022-12-15T02:00:31Z,2022-25642,0,0,09000064855005e6
FDA-2018-N-3240-0369,FDA,FDA-2018-N-3240,"List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act",Notice,General Notice,2022-11-23T05:00:00Z,2022,11,2022-11-23T05:00:00Z,2023-01-24T04:59:59Z,2023-01-24T02:01:08Z,2022-25549,0,0,09000064854fe4c0
FDA-2022-D-2922-0001,FDA,FDA-2022-D-2922,"Compounding Certain Beta-Lactam Products in Shortage Under Section
503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry;
Availability",Notice,Guidance,2022-11-23T05:00:00Z,2022,11,2022-11-23T05:00:00Z,,2022-11-23T14:38:36Z,2022-25622,0,0,09000064854fe37a
FDA-2022-N-2796-0001,FDA,FDA-2022-N-2796,"Bristol Myers Products Inc.; Proposal To Withdraw Approval of a New Drug
Application for Bufferin (Aspirin) Tablets; Opportunity for a Hearing",Notice,Withdrawal,2022-11-23T05:00:00Z,2022,11,2022-11-23T05:00:00Z,2023-01-24T04:59:59Z,2023-02-02T19:29:11Z,2022-25516,0,0,09000064854fe483
FDA-2022-N-2841-0001,FDA,FDA-2022-N-2841,Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting,Notice,Advisory Committee,2022-11-22T05:00:00Z,2022,11,2022-11-22T05:00:00Z,,2022-11-22T16:45:04Z,2022-25405,0,0,09000064854fb9dc
FDA-2022-N-2657-0001,FDA,FDA-2022-N-2657,"Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration’s Study of Assessing Physiological, Neural and Self-Reported Response to Tobacco Education Messages",Notice,60 Day Proposed Information Collection,2022-11-22T05:00:00Z,2022,11,2022-11-22T05:00:00Z,2023-01-24T04:59:59Z,2023-01-08T03:41:08Z,2022-25406,0,0,09000064854fbad4
FDA-2022-N-0009-0007,FDA,FDA-2022-N-0009,"Statement of Organization, Functions, and Delegations of Authority; Correction",Notice,Correction,2022-11-22T05:00:00Z,2022,11,2022-11-22T05:00:00Z,,2022-11-22T15:38:32Z,2022-25409,0,0,09000064854fba49
FDA-2011-N-0656-1300,FDA,FDA-2011-N-0656,Animal Drug User Fee Act; Public Meeting; Request for Comments,Notice,Request for Comments,2022-11-21T05:00:00Z,2022,11,2022-11-21T05:00:00Z,2022-12-20T04:59:59Z,2022-12-21T02:01:20Z,2022-25274,0,0,09000064854ef8f2
FDA-2022-N-2826-0001,FDA,FDA-2022-N-2826,"Allergan Sales, LLC, et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications",Notice,Withdrawal,2022-11-21T05:00:00Z,2022,11,2022-11-21T05:00:00Z,,2022-11-21T13:23:13Z,2022-25315,0,0,09000064854f814f
FDA-2007-D-0369-0693,FDA,FDA-2007-D-0369,Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability,Notice,Notice of Availability,2022-11-18T05:00:00Z,2022,11,2022-11-18T05:00:00Z,,2023-02-17T15:36:29Z,2022-25210,0,0,09000064854d0520
FDA-2022-N-2672-0002,FDA,FDA-2022-N-2672,"Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada; Public Meeting; Request for Comments",Notice,Public Meetings,2022-11-17T05:00:00Z,2022,11,2022-11-17T05:00:00Z,2023-01-18T04:59:59Z,2023-01-24T02:01:08Z,2022-25002,0,0,09000064854bdfde
FDA-2022-N-2672-0003,FDA,FDA-2022-N-2672,"Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada; Availability; Request for Comments",Notice,Notice of Availability,2022-11-17T05:00:00Z,2022,11,2022-11-17T05:00:00Z,2023-01-18T04:59:59Z,2023-01-19T02:01:06Z,2022-25001,0,0,09000064854bdfe4
FDA-2022-N-2673-0001,FDA,FDA-2022-N-2673,Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use; Request for Comments,Notice,Request for Comments,2022-11-16T05:00:00Z,2022,11,2022-11-16T05:00:00Z,2023-01-18T04:59:59Z,2023-01-19T02:00:34Z,2022-24874,0,0,09000064854bb10e
FDA-2019-N-2778-0005,FDA,FDA-2019-N-2778,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles",Notice,30 Day Proposed Information Collection,2022-11-15T05:00:00Z,2022,11,2022-11-15T05:00:00Z,,2022-11-15T15:54:09Z,2022-24801,0,0,09000064854b0d9e
FDA-2021-N-0526-0002,FDA,FDA-2021-N-0526,David Elias Mendoza: Final Debarment Order,Notice,General Notice,2022-11-15T05:00:00Z,2022,11,2022-11-15T05:00:00Z,,2022-11-15T15:10:50Z,2022-24805,0,0,09000064854b0d10
FDA-2022-D-2512-0001,FDA,FDA-2022-D-2512,Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin; International Council for Harmonisation; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2022-11-14T05:00:00Z,2022,11,2022-11-14T05:00:00Z,,2022-11-14T16:04:58Z,2022-24685,0,0,09000064854aab74
FDA-2019-E-2271-0006,FDA,FDA-2019-E-2271,"Determination of Regulatory Review Period for Purposes of Patent Extension; PREVYMIS IV Solution, New Drug Application 209940",Notice,Determinations,2022-11-14T05:00:00Z,2022,11,2022-11-14T05:00:00Z,2023-01-14T04:59:59Z,2022-11-14T16:28:59Z,2022-24719,0,0,09000064854aac1b
FDA-2021-D-0997-0006,FDA,FDA-2021-D-0997,"Referencing the Definition of ‘‘Device’’ in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and
Other Public Documents; Guidance for Industry and Food and Drug Administration Staff; Availability - Final Guidance",Notice,Notice of Availability,2022-11-14T05:00:00Z,2022,11,2022-11-14T05:00:00Z,,2022-11-14T15:38:42Z,2022-24707,0,0,09000064854aaa05
FDA-2019-E-2273-0006,FDA,FDA-2019-E-2273,"Determination of Regulatory Review Period for Purposes of Patent Extension; PREVYMIS, New Drug Application 209939",Notice,Determinations,2022-11-14T05:00:00Z,2022,11,2022-11-14T05:00:00Z,2023-01-14T04:59:59Z,2022-11-14T15:02:40Z,2022-24718,0,0,09000064854aa583
FDA-2016-N-2683-0012,FDA,FDA-2016-N-2683,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support
Social and Behavioral Research as Used by the Food and Drug Administration",Notice,30 Day Proposed Information Collection,2022-11-14T05:00:00Z,2022,11,2022-11-14T05:00:00Z,,2022-11-14T18:04:53Z,2022-24693,0,0,09000064854aa9fd
FDA-2022-D-0697-0001,FDA,FDA-2022-D-0697,Sameness Evaluations in an Abbreviated New Drug Application—Active Ingredients; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2022-11-09T05:00:00Z,2022,11,2022-11-09T05:00:00Z,,2022-11-09T13:49:02Z,2022-24432,0,0,090000648549d539
FDA-2020-E-2046-0005,FDA,FDA-2020-E-2046,Determination of Regulatory Review Period for Purposes of Patent Extension; NEXLETOL,Notice,Determinations,2022-11-09T05:00:00Z,2022,11,2022-11-09T05:00:00Z,2023-01-10T04:59:59Z,2022-11-10T02:00:26Z,2022-24431,0,0,090000648549d0f5
FDA-2020-E-2257-0006,FDA,FDA-2020-E-2257,Determination of Regulatory Review Period for Purposes of Patent Extension; XCOPRI,Notice,Determinations,2022-11-09T05:00:00Z,2022,11,2022-11-09T05:00:00Z,2023-01-10T04:59:59Z,2022-11-10T02:00:38Z,2022-24457,0,0,090000648549d5cd
FDA-2022-N-2174-0002,FDA,FDA-2022-N-2174,Oncologic Drugs Advisory Committee; Cancellation,Notice,Meeting,2022-11-09T05:00:00Z,2022,11,2022-11-09T05:00:00Z,,2022-11-09T13:40:59Z,2022-24470,0,0,090000648549d61a
FDA-2021-E-0381-0006,FDA,FDA-2021-E-0381,Determination of Regulatory Review Period for Purposes of Patent Extension; TISSUEBLUE,Notice,Determinations,2022-11-09T05:00:00Z,2022,11,2022-11-09T05:00:00Z,2023-01-10T04:59:59Z,2022-11-09T13:42:05Z,2022-24434,0,0,090000648549d0f1
FDA-2020-E-1995-0005,FDA,FDA-2020-E-1995,Determination of Regulatory Review Period for Purposes of Patent Extension; NOURIANZ,Notice,Determinations,2022-11-07T05:00:00Z,2022,11,2022-11-07T05:00:00Z,2023-01-07T04:59:59Z,2022-11-07T18:21:13Z,2022-24217,0,0,0900006485492c81
FDA-2016-N-2066-0008,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,2022-11-07T05:00:00Z,2022,11,2022-11-07T05:00:00Z,2023-01-07T04:59:59Z,2022-11-07T13:49:02Z,2022-24110,0,0,0900006485492c80
FDA-2021-D-0776-0013,FDA,FDA-2021-D-0776,Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Guidance for Industry; Availability,Notice,Guidance,2022-11-07T05:00:00Z,2022,11,2022-11-07T05:00:00Z,,2022-11-07T13:31:59Z,2022-24112,0,0,0900006485492c29
FDA-2022-N-2671-0001,FDA,FDA-2022-N-2671,Drug Supply Chain Security Act Implementation and Readiness Efforts for 2023; Public Meeting; Request for Comments,Notice,Request for Comments,2022-11-07T05:00:00Z,2022,11,2022-11-07T05:00:00Z,2023-02-07T04:59:59Z,2023-02-25T02:00:19Z,2022-24212,0,0,0900006485492dea
FDA-2018-E-4324-0003,FDA,FDA-2018-E-4324,Determination of Regulatory Review Period for Purposes of Patent Extension; ANGELMED GUARDIAN SYSTEM,Notice,Determinations,2022-11-07T05:00:00Z,2022,11,2022-11-07T05:00:00Z,2023-01-07T04:59:59Z,2022-11-07T13:39:11Z,2022-24216,0,0,0900006485492c7c
FDA-2013-N-0557-0010,FDA,FDA-2013-N-0557,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance of Medical Devices,Notice,30 Day Proposed Information Collection,2022-11-07T05:00:00Z,2022,11,2022-11-07T05:00:00Z,2022-12-08T04:59:59Z,2022-11-07T18:23:16Z,2022-24232,0,0,0900006485492deb
FDA-2019-D-1469-0015,FDA,FDA-2019-D-1469,M10 Bioanalytical Method Validation and Study Sample Analysis; International Council for Harmonisation; Guidance for Industry; Availability,Notice,Notice of Availability,2022-11-07T05:00:00Z,2022,11,2022-11-07T05:00:00Z,,2022-11-07T13:45:18Z,2022-24113,0,0,0900006485492c7d
FDA-2010-D-0350-0033,FDA,FDA-2010-D-0350,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Retailer Training Programs,Notice,30 Day Proposed Information Collection,2022-11-07T05:00:00Z,2022,11,2022-11-07T05:00:00Z,,2022-11-07T15:17:07Z,2022-24218,0,0,0900006485492c7a
FDA-2020-E-1994-0005,FDA,FDA-2020-E-1994,Determination of Regulatory Review Period for Purposes of Patent Extension; NOURIANZ,Notice,Determinations,2022-11-07T05:00:00Z,2022,11,2022-11-07T05:00:00Z,2023-01-07T04:59:59Z,2022-11-07T18:20:20Z,2022-24217,0,0,0900006485489888
FDA-2022-N-0150-0007,FDA,FDA-2022-N-0150,Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability,Notice,Announcement,2022-11-04T04:00:00Z,2022,11,2022-11-04T04:00:00Z,,2022-11-04T14:25:30Z,2022-24072,0,0,09000064854883e3
FDA-2022-N-1961-0038,FDA,FDA-2022-N-1961,Advancing Premarket Safety Analytics Workshop; Request for Comments,Notice,Request for Comments,2022-11-03T04:00:00Z,2022,11,2022-11-03T04:00:00Z,2022-12-06T04:59:59Z,2022-12-07T02:01:18Z,2022-23925,0,0,090000648548119a
FDA-2020-D-2107-0009,FDA,FDA-2020-D-2107,"Cross Labeling Oncology Drugs in Combination Regimens; Guidance for
Industry; Availability",Notice,Notice of Availability,2022-11-03T04:00:00Z,2022,11,2022-11-03T04:00:00Z,,2022-11-03T12:37:22Z,2022-23866,0,0,09000064854812db
FDA-2021-N-0341-0006,FDA,FDA-2021-N-0341,Agency Information Collection Activities; Proposed Collection; Comment Request; Federal-State Food Regulatory Program Standards,Notice,60 Day Proposed Information Collection,2022-11-03T04:00:00Z,2022,11,2022-11-03T04:00:00Z,2023-01-04T04:59:59Z,2023-01-04T02:01:00Z,2022-23919,0,0,09000064854811e2
FDA-2022-D-2336-0001,FDA,FDA-2022-D-2336,"Assessing User Fees Under the Overthe-Counter Monograph Drug User Fee Program; Draft Guidance for Industry;
Availability",Notice,Notice of Availability,2022-11-02T04:00:00Z,2022,11,,,2022-11-02T12:14:05Z,2022-23791,0,0,090000648547b381
FDA-2013-N-0796-0012,FDA,FDA-2013-N-0796,Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications by the Food and Drug Administration’s Center for Devices and Radiological Health,Notice,60 Day Proposed Information Collection,2022-11-02T04:00:00Z,2022,11,2022-11-02T04:00:00Z,2023-01-04T04:59:59Z,2022-11-02T14:44:21Z,2022-23781,0,0,090000648547b419
FDA-2021-D-0669-0008,FDA,FDA-2021-D-0669,S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmonisation; Guidance for Industry; Availability,Notice,Notice of Availability,2022-11-02T04:00:00Z,2022,11,,,2022-11-02T12:34:04Z,2022-23787,0,0,090000648547b3db
FDA-2013-D-0446-0015,FDA,FDA-2013-D-0446,Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2022-11-02T04:00:00Z,2022,11,,,2022-11-02T13:00:13Z,2022-23785,0,0,090000648547b466
FDA-2016-N-3535-0009,FDA,FDA-2016-N-3535,Agency Information Collection Activities; Proposed Collection; Comment Request; Special Protocol Assessment; Guidance for Industry,Notice,60 Day Proposed Information Collection,2022-11-01T04:00:00Z,2022,11,2022-11-01T04:00:00Z,2023-01-04T04:59:59Z,2023-01-05T02:00:51Z,2022-23727,0,0,0900006485477988