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withdrawn,object_id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-2021-N-0341-0005,FDA,FDA-2021-N-0341,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T14:29:28Z,2021-28362,0,0,0900006484f005d4
FDA-2015-N-1837-0011,FDA,FDA-2015-N-1837,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T14:29:00Z,2021-28362,0,0,0900006484f005d5
FDA-2020-N-1307-0024,FDA,FDA-2020-N-1307,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T14:32:10Z,2021-28362,0,0,0900006484f005cf
FDA-2021-N-0356-0003,FDA,FDA-2021-N-0356,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T14:31:08Z,2021-28362,0,0,0900006484f005d1
FDA-2018-N-1857-0012,FDA,FDA-2018-N-1857,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T14:30:05Z,2021-28362,0,0,0900006484f005d3
FDA-2011-D-0147-0039,FDA,FDA-2011-D-0147,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T14:30:37Z,2021-28362,0,0,0900006484f005d2
FDA-2012-N-0536-0016,FDA,FDA-2012-N-0536,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T14:25:40Z,2021-28362,0,0,0900006484f003cd
FDA-2014-N-1048-0011,FDA,FDA-2014-N-1048,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2022-08-24T14:18:15Z,2021-28362,0,0,0900006484f005d0
FDA-2013-N-1529-0026,FDA,FDA-2013-N-1529,"Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reclassification
Petitions for Medical Devices",Notice,30 Day Proposed Information Collection,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,2022-01-29T04:59:59Z,2021-12-29T17:25:49Z,2021-28299,0,0,0900006484effa24
FDA-2013-N-1529-0027,FDA,FDA-2013-N-1529,"Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reclassification
Petitions for Medical Devices",Notice,30 Day Proposed Information Collection,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,2022-01-29T04:59:59Z,2022-01-29T02:00:36Z,2021-28305,0,0,0900006484effb4a
FDA-2012-P-1189-0015,FDA,FDA-2012-P-1189,Canned Tuna Deviating From the Standard of Identity; Amendment of Temporary Marketing Permits,Notice,General Notice,2021-12-28T05:00:00Z,2021,12,2021-12-28T05:00:00Z,,2021-12-28T17:40:01Z,2021-28164,0,0,0900006484efed05
FDA-2021-N-1252-0001,FDA,FDA-2021-N-1252,"Panray Corp. Sub Ormont Drug and Chemical Co., Inc., et al.; Proposal To Withdraw Approval of Three New Drug Applications; Opportunity for a Hearing",Notice,Withdrawal,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,2022-02-26T04:59:59Z,2021-12-27T14:24:54Z,2021-27946,0,0,0900006484efd6cc
FDA-2021-D-0367-0001,FDA,FDA-2021-D-0367,"Compliance Policy Guide Sec. 540.525
Scombrotoxin (Histamine)-Forming
Fish and Fishery Products—
Decomposition and Histamine;
Availability",Notice,Notice of Availability,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,2022-02-26T04:59:59Z,2022-03-15T15:47:30Z,2021-28053,0,0,0900006484efd850
FDA-2019-D-2330-0034,FDA,FDA-2019-D-2330,Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers; Guidance for Industry; Availability,Notice,Notice of Availability,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T14:29:13Z,2021-28051,0,0,0900006484efd807
FDA-2020-D-1118-0006,FDA,FDA-2020-D-1118,"Non-Clinical and Clinical Investigation
of Devices Used for the Treatment of
Benign Prostatic Hyperplasia;
Guidance for Industry and Food and
Drug Administration Staff; Availability",Notice,Notice of Availability,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T14:34:07Z,2021-27919,0,0,0900006484efd897
FDA-2021-D-0980-0002,FDA,FDA-2021-D-0980,Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,2022-03-25T03:59:59Z,2023-11-16T22:21:11Z,2021-27812,0,0,0900006484ee208a
FDA-2021-D-0996-0002,FDA,FDA-2021-D-0996,Technical Considerations for Medical Devices With Physiologic Closed-Loop Control Technology; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T14:34:15Z,2021-27825,0,0,0900006484ee7f1d
FDA-2019-D-5606-0004,FDA,FDA-2019-D-5606,"Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use- Premarket Notification (510(k))
Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T14:01:37Z,2021-27823,0,0,0900006484ee7f15
FDA-2021-D-1149-0001,FDA,FDA-2021-D-1149,Transition Plan for Medical Devices Issued Emergency Use Authorizations During the Coronavirus Disease 2019 Public Health Emergency; Draft Guidance for Industry and Food and Drug Administration Staff;  Availability; Agency Information Collection Activities; Proposed Collection; Comment Request,Notice,Notice of Availability,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2022-04-02T23:44:43Z,2021-27891,0,0,0900006484ee7e2c
FDA-2018-N-4206-0004,FDA,FDA-2018-N-4206,Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Small Business Qualification and Certification,Notice,60 Day Proposed Information Collection,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,2022-02-23T04:59:59Z,2022-02-23T02:00:25Z,2021-27889,0,0,0900006484ee7e8c
FDA-2021-D-1118-0001,FDA,FDA-2021-D-1118,Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 Public Health Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request,Notice,Notice of Availability,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2022-02-02T02:00:22Z,2021-27892,0,0,0900006484ee7e8e
FDA-2021-D-1128-0001,FDA,FDA-2021-D-1128,"Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for
Industry, Investigators, and Other Stakeholders; Availability",Notice,Notice of Availability,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T14:24:00Z,2021-27894,0,0,0900006484ee7ee5
FDA-2018-N-1967-0005,FDA,FDA-2018-N-1967,"Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Biosimilars User Fee Program",Notice,30 Day Proposed Information Collection,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,2022-01-22T04:59:59Z,2021-12-22T13:37:54Z,2021-27680,0,0,0900006484ee0c68
FDA-2021-P-0923-0004,FDA,FDA-2021-P-0923,"Determination That ANTIZOL (Fomepizole) Injection, 1.5 Grams/1.5 Milliliters, Was Not Withdrawn From
Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:22:01Z,2021-27699,0,0,0900006484ee09d0
FDA-2021-D-0756-0001,FDA,FDA-2021-D-0756,Validation and Verification of Analytical Testing Methods Used for Tobacco Products; Draft Guidance for Industry; Availability; Request for Comments,Notice,Notice of Availability,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,2022-02-23T04:59:59Z,2022-09-02T01:00:54Z,2021-27719,0,0,0900006484ee0b8d
FDA-2021-P-0375-0006,FDA,FDA-2021-P-0375,"Determination That Alcohol and Dextrose Injection, 5 Milliliters/100 Milliliters, 5 Grams/100 Milliliters; and
10 Milliliters/100 Milliliters, 5 Grams/100 Milliliters, Were Withdrawn From Sale for Reasons of Safety or
Effectiveness",Notice,Determinations,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:26:27Z,2021-27696,0,0,0900006484ee0a01
FDA-2021-D-0548-0011,FDA,FDA-2021-D-0548,"Data Standards for Drug and BiologicalProduct Submissions Containing Real-
World Data; Draft Guidance for Industry; Availability; Extension of Comment Period",Notice,Extension of Comment Period,2021-12-21T05:00:00Z,2021,12,2021-12-21T05:00:00Z,2022-02-05T04:59:59Z,2022-02-05T02:00:49Z,2021-27521,0,0,0900006484ed8389
FDA-2021-N-1212-0001,FDA,FDA-2021-N-1212,Wound Healing Scientific Workshop; Public Workshop; Request for Comments,Notice,Request for Comments,2021-12-20T05:00:00Z,2021,12,2021-12-20T05:00:00Z,2022-06-29T03:59:59Z,2022-06-29T01:00:38Z,2021-27459,0,0,0900006484ed6200
FDA-2021-D-0241-0001,FDA,FDA-2021-D-0241,Inspection of Injectable Products for Visible Particulates; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2021-12-17T05:00:00Z,2021,12,2021-12-17T05:00:00Z,2022-02-16T04:59:59Z,2022-03-13T00:07:08Z,2021-27351,0,0,0900006484ed1d58
FDA-2019-N-3926-0005,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,2021-12-17T05:00:00Z,2021,12,2021-12-17T05:00:00Z,2022-02-16T04:59:59Z,2021-12-17T17:01:39Z,2021-27376,0,0,0900006484ed13d2
FDA-2013-N-1425-0198,FDA,FDA-2013-N-1425,"Agency Information Collection Activities; Proposed Collection; Comment Request; Mitigation Strategies To Protect Food Against
Intentional Adulteration",Notice,60 Day Proposed Information Collection,2021-12-17T05:00:00Z,2021,12,2021-12-17T05:00:00Z,2022-02-16T04:59:59Z,2022-08-22T17:54:47Z,2021-27285,0,0,0900006484ed1e30
FDA-2021-D-0997-0001,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; Draft Guidance for Industry and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2021-12-16T05:00:00Z,2021,12,2021-12-16T05:00:00Z,2022-02-15T04:59:59Z,2022-02-12T02:00:16Z,2021-27266,0,0,0900006484ecfac6
FDA-2021-N-0505-0002,FDA,FDA-2021-N-0505,Julia Fees: Final Debarment Order,Notice,General Notice,2021-12-15T05:00:00Z,2021,12,2021-12-15T05:00:00Z,,2021-12-15T16:12:55Z,2021-27056,0,0,0900006484ecae26
FDA-2021-N-0346-0002,FDA,FDA-2021-N-0346,"Jeffrey A. Styron: Final Debarment
Order",Notice,General Notice,2021-12-15T05:00:00Z,2021,12,2021-12-15T05:00:00Z,,2021-12-15T16:18:20Z,2021-27053,0,0,0900006484ecb00b
FDA-2018-N-3758-0009,FDA,FDA-2018-N-3758,"Agency Information Collection
Activities; Proposed Collection;
Comment Request; Expanded Access
to Investigational Drugs for Treatment
Use",Notice,60 Day Proposed Information Collection,2021-12-14T05:00:00Z,2021,12,2021-12-14T05:00:00Z,2022-02-15T04:59:59Z,2023-04-27T14:49:59Z,2021-26990,0,0,0900006484ec65df
FDA-2021-N-1287-0001,FDA,FDA-2021-N-1287,"Actavis LLC, et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications",Notice,Withdrawal,2021-12-13T05:00:00Z,2021,12,2021-12-13T05:00:00Z,,2021-12-13T14:05:07Z,2021-26892,0,0,0900006484ec0819
FDA-2020-D-1301-0006,FDA,FDA-2020-D-1301,Q3C(R8) Impurities: Guidance for Residual Solvents; International Council for Harmonisation; Guidance for Industry; Availability,Notice,Notice of Availability,2021-12-13T05:00:00Z,2021,12,2021-12-13T05:00:00Z,,2021-12-13T14:32:26Z,2021-26889,0,0,0900006484ec09b9
FDA-2021-D-0406-0001,FDA,FDA-2021-D-0406,Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2021-12-13T05:00:00Z,2021,12,2021-12-13T05:00:00Z,,2021-12-13T13:50:15Z,2021-26923,0,0,0900006484ec05aa
FDA-2021-N-1285-0001,FDA,FDA-2021-N-1285,Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments,Notice,Request for Comments,2021-12-13T05:00:00Z,2021,12,2021-12-13T05:00:00Z,2022-02-10T04:59:59Z,2022-02-10T02:00:38Z,2021-26891,0,0,0900006484ec07e5
FDA-2021-D-0861-0001,FDA,FDA-2021-D-0861,Cover Letter Attachments for Controlled Correspondences and Abbreviated New Drug Application Submissions; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2021-12-13T05:00:00Z,2021,12,2021-12-13T05:00:00Z,,2021-12-13T14:27:05Z,2021-26893,0,0,0900006484ec08ed
FDA-2020-D-2307-0052,FDA,FDA-2020-D-2307,"Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-
Making for Drug and Biological Products; Draft Guidance for Industry; Reopening of the Comment Period",Notice,Notice of Availability,2021-12-10T05:00:00Z,2021,12,2021-12-10T05:00:00Z,2022-01-25T04:59:59Z,2024-07-25T12:53:56Z,2021-26699,0,0,0900006484eb7ef1
FDA-2021-D-1096-0001,FDA,FDA-2021-D-1096,"Chronic Rhinosinusitis With Nasal
Polyps: Developing Drugs for
Treatment; Draft Guidance for
Industry; Availability",Notice,Notice of Availability,2021-12-10T05:00:00Z,2021,12,2021-12-10T05:00:00Z,2022-02-09T04:59:59Z,2022-02-09T02:00:44Z,2021-26733,0,0,0900006484eb80f8
FDA-2021-N-0918-0002,FDA,FDA-2021-N-0918,"Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Labeling
Requirements for Prescription Drugs",Notice,30 Day Proposed Information Collection,2021-12-10T05:00:00Z,2021,12,2021-12-10T05:00:00Z,2022-01-11T04:59:59Z,2021-12-14T02:00:50Z,2021-26730,0,0,0900006484eb8075
FDA-2017-D-2802-0016,FDA,FDA-2017-D-2802,"Chemistry, Manufacturing, and
Controls Postapproval Manufacturing
Changes for Specified Biological
Products To Be Documented in Annual
Reports; Guidance for Industry;
Availability",Notice,Notice of Availability,2021-12-10T05:00:00Z,2021,12,2021-12-10T05:00:00Z,,2021-12-10T15:14:13Z,2021-26734,0,0,0900006484eb80f4
FDA-2020-D-1518-0016,FDA,FDA-2020-D-1518,Development of Anti-Infective Drug Products for the Pediatric Population; Guidance for Industry; Availability,Notice,Notice of Availability,2021-12-10T05:00:00Z,2021,12,2021-12-10T05:00:00Z,,2021-12-10T13:30:21Z,2021-26737,0,0,0900006484eb7f61
FDA-2021-D-1214-0001,FDA,FDA-2021-D-1214,"Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry;
Availability",Notice,Notice of Availability,2021-12-09T05:00:00Z,2021,12,2021-12-09T05:00:00Z,2022-03-10T04:59:59Z,2024-11-07T00:34:19Z,2021-26640,1,0,0900006484eb23b7
FDA-2011-D-0125-0017,FDA,FDA-2011-D-0125,"Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Establishing that a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007",Notice,60 Day Proposed Information Collection,2021-12-09T05:00:00Z,2021,12,2021-12-09T05:00:00Z,2022-02-08T04:59:59Z,2021-12-09T14:32:05Z,2021-26652,0,0,0900006484eb237b
FDA-2004-N-0451-0050,FDA,FDA-2004-N-0451,"Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 056",Notice,Announcement,2021-12-09T05:00:00Z,2021,12,2021-12-09T05:00:00Z,2021-12-10T04:59:59Z,2024-11-07T00:34:20Z,2021-26635,1,0,0900006484eb23ba
FDA-2021-D-0373-0003,FDA,FDA-2021-D-0373,"Tobacco Product User Fees: Responses to Frequently Asked
Questions; Guidance for Industry; Availability",Notice,Notice of Availability,2021-12-09T05:00:00Z,2021,12,2021-12-09T05:00:00Z,,2021-12-09T13:52:03Z,2021-26651,0,0,0900006484eb24a7
FDA-2021-N-1194-0001,FDA,FDA-2021-N-1194,Fresenius Kabi Deutschland GmbH; Withdrawal of Approval of New Drug Application of Hydroxyethyl Starch,Notice,Withdrawal,2021-12-09T05:00:00Z,2021,12,2021-12-09T05:00:00Z,,2021-12-09T14:55:20Z,2021-26648,0,0,0900006484eb24ed
FDA-2021-D-1139-0001,FDA,FDA-2021-D-1139,"Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2021-12-08T05:00:00Z,2021,12,2021-12-08T05:00:00Z,,2021-12-08T14:15:39Z,2021-26454,0,0,0900006484eaee8c
FDA-2021-D-1140-0001,FDA,FDA-2021-D-1140,Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations; Draft Guidance for Sponsor-Investigators; Availability,Notice,Notice of Availability,2021-12-08T05:00:00Z,2021,12,2021-12-08T05:00:00Z,,2021-12-08T14:19:49Z,2021-26453,0,0,0900006484eaeede
FDA-1975-N-0336-0115,FDA,FDA-1975-N-0336,Pathibamate Tablets; Drugs for Human Use; Drug Efficacy Study Implementation; Withdrawal of Approval of New Drug Application,Notice,Withdrawal,2021-12-07T05:00:00Z,2021,12,,,2021-12-07T16:26:29Z,52 FR 22687,0,0,09000064805c7bff
FDA-2018-N-0417-0005,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,2021-12-03T05:00:00Z,2021,12,2021-12-03T05:00:00Z,,2021-12-03T16:25:28Z,2021-26258,0,0,0900006484e9c7d4
FDA-2018-N-0417-0006,FDA,FDA-2018-N-0417,Request for Nominations on the National Mammography Quality Assurance Advisory Committee,Notice,Request for Nominations,2021-12-03T05:00:00Z,2021,12,2021-12-03T05:00:00Z,,2021-12-03T16:43:54Z,2021-26264,0,0,0900006484e9c85b
FDA-2011-N-0921-19184,FDA,FDA-2011-N-0921,"Agency Information Collection Activities; Proposed Collection; Comment Request; Standards for the
Growing, Harvesting, Packaging, and
Holding of Produce for Human
Consumption",Notice,60 Day Proposed Information Collection,2021-12-03T05:00:00Z,2021,12,2021-12-03T05:00:00Z,2022-02-02T04:59:59Z,2021-12-04T23:26:08Z,2021-26261,0,0,0900006484e9c823
FDA-2012-N-0280-0010,FDA,FDA-2012-N-0280,"Agency Information Collection
Activities; Proposed Collection;
Comment Request; Financial
Disclosure by Clinical Investigators",Notice,60 Day Proposed Information Collection,2021-12-02T05:00:00Z,2021,12,2021-12-02T05:00:00Z,2022-02-01T04:59:59Z,2021-12-03T02:00:32Z,2021-26182,0,0,0900006484e936d4
FDA-2008-D-0530-0022,FDA,FDA-2008-D-0530,"Agency Information Collection Activities; Proposed Collection ;Comment Request; Tropical 
 Disease Priority Review Vouchers",Notice,60 Day Proposed Information Collection,2021-12-02T05:00:00Z,2021,12,2021-12-02T05:00:00Z,2022-02-01T04:59:59Z,2022-08-22T17:58:57Z,2021-26196,0,0,0900006484e935d5
FDA-2021-N-1145-0001,FDA,FDA-2021-N-1145,"Aurolife Pharma LLC, et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications",Notice,Withdrawal,2021-12-02T05:00:00Z,2021,12,2021-12-02T05:00:00Z,,2021-12-02T18:58:52Z,2021-26170,0,0,0900006484e93612
FDA-2021-N-1222-0001,FDA,FDA-2021-N-1222,"Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Labeling:
Notification Procedures for Statements
on Dietary Supplements",Notice,60 Day Proposed Information Collection,2021-12-02T05:00:00Z,2021,12,2021-12-02T05:00:00Z,2022-02-01T04:59:59Z,2021-12-02T18:51:32Z,2021-26172,0,0,0900006484e935d7
FDA-2019-N-2809-0003,FDA,FDA-2019-N-2809,Advisory Committee; Patient Engagement Advisory Committee; Renewal,Notice,Renewals,2021-12-01T05:00:00Z,2021,12,2021-12-01T05:00:00Z,,2021-12-01T14:57:52Z,2021-26118,0,0,0900006484e8f357
FDA-2020-E-2224-0006,FDA,FDA-2020-E-2224,Determination of Regulatory Review Period for Purposes of Patent Extension; ZEPZELCA,Notice,Determinations,2021-11-30T05:00:00Z,2021,11,2021-11-30T05:00:00Z,2022-02-01T04:59:59Z,2024-02-05T18:15:56Z,2021-26009,0,0,0900006484e8c17a
FDA-2018-N-3233-0003,FDA,FDA-2018-N-3233,"Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic
Product Radiation Safety Standards Committee",Notice,Call for Nominations,2021-11-30T05:00:00Z,2021,11,2021-11-30T05:00:00Z,,2021-11-30T17:39:03Z,2021-26002,0,0,0900006484e8bcf5
FDA-2021-D-1146-0001,FDA,FDA-2021-D-1146,"Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological
Products; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2021-11-30T05:00:00Z,2021,11,2021-11-30T05:00:00Z,2022-03-01T04:59:59Z,2022-03-02T02:00:49Z,2021-26006,0,0,0900006484e8bbad
FDA-2005-N-0101-0005,FDA,FDA-2005-N-0101,"Agency Information Collection Activities; Proposed Collections; Comment Request; Prescription Drug
User Fee Program",Notice,60 Day Proposed Information Collection,2021-11-30T05:00:00Z,2021,11,2021-11-30T05:00:00Z,2022-02-01T04:59:59Z,2021-12-01T16:11:24Z,2021-26079,0,0,0900006484e8bbb4
FDA-2014-N-1721-0016,FDA,FDA-2014-N-1721,Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements,Notice,60 Day Proposed Information Collection,2021-11-24T05:00:00Z,2021,11,2021-11-24T05:00:00Z,2022-01-25T04:59:59Z,2023-03-14T21:05:23Z,2021-25615,0,0,0900006484e7b858
FDA-2020-E-2122-0006,FDA,FDA-2020-E-2122,Determination of Regulatory Review Period for Purposes of Patent Extension; TRODELVY,Notice,Determinations,2021-11-24T05:00:00Z,2021,11,2021-11-24T05:00:00Z,2022-05-24T03:59:59Z,2022-01-29T02:00:34Z,2021-25612,0,0,0900006484e7b859
FDA-2021-N-0405-0002,FDA,FDA-2021-N-0405,Maytee Lledo: Final Debarment Order,Notice,General Notice,2021-11-23T05:00:00Z,2021,11,2021-11-23T05:00:00Z,,2021-11-23T15:07:39Z,2021-25589,0,0,0900006484e7599d
FDA-2018-N-4465-0004,FDA,FDA-2018-N-4465,Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices,Notice,60 Day Proposed Information Collection,2021-11-22T05:00:00Z,2021,11,2021-11-22T05:00:00Z,2022-01-22T04:59:59Z,2021-11-27T02:00:35Z,2021-25323,0,0,0900006484e711e9
FDA-1978-N-0018-15847,FDA,FDA-1978-N-0018,Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-The-Counter Human Use; Over-The-Counter Monograph Proposed Order (OTC 000008) Extension of Comment Period,Notice,Extension of Comment Period,2021-11-22T05:00:00Z,2021,11,2021-11-22T05:00:00Z,2021-12-28T04:59:59Z,2021-12-25T02:00:48Z,2021-25371,0,0,0900006484e711a4
FDA-2012-N-1021-0075,FDA,FDA-2012-N-1021,"Notice to Public of Website Location of
Center for Devices and Radiological
Health Fiscal Year 2022 Proposed
Guidance Development",Notice,Correction,2021-11-19T05:00:00Z,2021,11,2021-11-19T05:00:00Z,,2021-11-19T16:21:42Z,C1-2021-23392,0,0,0900006484e655f2
FDA-2009-D-0268-0024,FDA,FDA-2009-D-0268,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling of Certain
Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration",Notice,30 Day Proposed Information Collection,2021-11-19T05:00:00Z,2021,11,2021-11-19T05:00:00Z,2021-12-21T04:59:59Z,2021-11-19T15:53:05Z,2021-25300,0,0,0900006484e66010
FDA-2018-N-3404-0005,FDA,FDA-2018-N-3404,Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Program,Notice,60 Day Proposed Information Collection,2021-11-19T05:00:00Z,2021,11,2021-11-19T05:00:00Z,2022-01-19T04:59:59Z,2021-11-19T16:10:41Z,2021-25294,0,0,0900006484e65f35
FDA-2021-N-1192-0001,FDA,FDA-2021-N-1192,Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notification Procedure,Notice,60 Day Proposed Information Collection,2021-11-19T05:00:00Z,2021,11,2021-11-19T05:00:00Z,2022-01-19T04:59:59Z,2022-01-19T02:00:28Z,2021-25302,0,0,0900006484e655f6
FDA-2018-N-3031-0005,FDA,FDA-2018-N-3031,"Agency Information Collection Activities; Proposed Collection;
Comment Request; Tobacco Products, User Fees, Requirements for the
Submission of Data Needed To Calculate User Fees for Domestic
Manufacturers and Importers of Tobacco Products",Notice,60 Day Proposed Information Collection,2021-11-19T05:00:00Z,2021,11,2021-11-19T05:00:00Z,2022-01-19T04:59:59Z,2021-11-19T14:56:20Z,2021-25306,0,0,0900006484e65f9d
FDA-2012-N-1021-0078,FDA,FDA-2012-N-1021,"Notice to Public of Website Location of
Center for Devices and Radiological
Health Fiscal Year 2022 Proposed
Guidance Development",Notice,Correction,2021-11-19T05:00:00Z,2021,11,2021-11-19T05:00:00Z,,2021-12-02T17:57:56Z,C1-2021-23,0,0,0900006484e66067
FDA-2019-E-5389-0006,FDA,FDA-2019-E-5389,Determination of Regulatory Review Period for Purposes of Patent Extension; SUNOSI,Notice,Determinations,2021-11-19T05:00:00Z,2021,11,2021-11-19T05:00:00Z,2022-05-19T03:59:59Z,2021-11-19T16:16:11Z,2021-25297,0,0,0900006484e65e47
FDA-2021-N-1195-0001,FDA,FDA-2021-N-1195,"Discovery Therapeutics, LLC, et al.; Withdrawal of Approval of 18 Abbreviated New Drug Applications",Notice,Withdrawal,2021-11-18T05:00:00Z,2021,11,2021-11-18T05:00:00Z,,2021-11-18T15:35:44Z,2021-25111,0,0,0900006484e5f2db
FDA-1992-N-0011-0009,FDA,FDA-1992-N-0011,Sanyasi Raju Kalidindi; Grant of Special Termination,Notice,Termination of Statutory Disbarment,2021-11-16T05:00:00Z,2021,11,2021-11-16T05:00:00Z,,2021-11-16T18:23:09Z,2021-24973,0,0,0900006484e4dfd1
FDA-2020-E-2167-0006,FDA,FDA-2020-E-2167,Determination of Regulatory Review Period for Purposes of Patent Extension; QINLOCK,Notice,Determinations,2021-11-16T05:00:00Z,2021,11,2021-11-16T05:00:00Z,2022-01-19T04:59:59Z,2021-11-16T18:16:22Z,2021-24978,0,0,0900006484e4dfcd
FDA-2020-E-2168-0006,FDA,FDA-2020-E-2168,Determination of Regulatory Review Period for Purposes of Patent Extension; QINLOCK,Notice,Determinations,2021-11-16T05:00:00Z,2021,11,2021-11-16T05:00:00Z,2022-01-19T04:59:59Z,2021-11-16T18:18:00Z,2021-24978,0,0,0900006484e4ebd2
FDA-2018-N-3353-0004,FDA,FDA-2018-N-3353,Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Distribution Reports and Recordkeeping,Notice,60 Day Proposed Information Collection,2021-11-09T05:00:00Z,2021,11,2021-11-09T05:00:00Z,2022-01-11T04:59:59Z,2021-11-09T14:51:54Z,2021-24433,0,0,0900006484e37a15
FDA-2014-N-1960-0028,FDA,FDA-2014-N-1960,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program,Notice,30 Day Proposed Information Collection,2021-11-09T05:00:00Z,2021,11,2021-11-09T05:00:00Z,2021-12-10T04:59:59Z,2021-12-10T02:00:46Z,2021-24432,0,0,0900006484e37ac8
FDA-2020-E-2232-0006,FDA,FDA-2020-E-2232,Determination of Regulatory Review Period for Purposes of Patent Extension; DOJOLVI,Notice,Determinations,2021-11-09T05:00:00Z,2021,11,2021-11-09T05:00:00Z,2022-01-11T04:59:59Z,2024-02-05T19:20:20Z,2021-24435,0,0,0900006484e37a46
FDA-2020-E-2204-0006,FDA,FDA-2020-E-2204,Determination of Regulatory Review Period for Purposes of Patent Extension; DOJOLVI,Notice,Determinations,2021-11-09T05:00:00Z,2021,11,2021-11-09T05:00:00Z,2022-01-11T04:59:59Z,2021-11-09T14:57:45Z,2021-24435,0,0,0900006484e37d4d
FDA-2007-D-0369-0567,FDA,FDA-2007-D-0369,Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability,Notice,Notice of Availability,2021-11-09T05:00:00Z,2021,11,2021-11-09T05:00:00Z,2022-01-11T04:59:59Z,2021-12-31T02:00:32Z,2021-24431,0,0,0900006484e37a93
FDA-1996-D-0405-0010,FDA,FDA-1996-D-0405,Compliance Policy Guide Sec. 110.100; Withdrawal of Guidance,Notice,Withdrawal,2021-11-05T04:00:00Z,2021,11,2021-11-05T04:00:00Z,,2021-11-05T17:24:38Z,2021-24234,0,0,0900006484e23a7d
FDA-2021-N-0515-0002,FDA,FDA-2021-N-0515,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biological Products",Notice,30 Day Proposed Information Collection,2021-11-05T04:00:00Z,2021,11,2021-11-05T04:00:00Z,2021-12-07T04:59:59Z,2021-11-05T17:18:42Z,2021-24236,0,0,0900006484e23a30
FDA-2020-E-1327-0006,FDA,FDA-2020-E-1327,Determination of Regulatory Review Period for Purposes of Patent Extension; ADAKVEO,Notice,Determinations,2021-11-04T04:00:00Z,2021,11,2021-11-04T04:00:00Z,2022-01-04T04:59:59Z,2021-11-09T19:40:14Z,2021-24070,0,0,0900006484e18049
FDA-2017-D-6784-0013,FDA,FDA-2017-D-6784,Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers; Guidance for Industry; Availability,Notice,Notice of Availability,2021-11-04T04:00:00Z,2021,11,2021-11-04T04:00:00Z,,2021-11-09T17:41:05Z,2021-24073,0,0,0900006484e17ebf
FDA-2020-E-2045-0006,FDA,FDA-2020-E-2045,Determination of Regulatory Review Period for Purposes of Patent Extension; AKLIEF,Notice,Determinations,2021-11-04T04:00:00Z,2021,11,2021-11-04T04:00:00Z,2022-01-04T04:59:59Z,2021-11-09T19:54:35Z,2021-24077,0,0,0900006484e1b479
FDA-2020-E-2042-0006,FDA,FDA-2020-E-2042,"Determination of Regulatory Review
Period for Purposes of Patent
Extension; AKLIEF",Notice,Determinations,2021-11-04T04:00:00Z,2021,11,2021-11-04T04:00:00Z,2022-01-04T04:59:59Z,2021-11-04T16:03:55Z,2021-24077,0,0,0900006484e1b478
FDA-2020-E-2023-0005,FDA,FDA-2020-E-2023,Determination of Regulatory Review Period for Purposes of Patent Extension; RECARBRIO,Notice,Determinations,2021-11-04T04:00:00Z,2021,11,2021-11-04T04:00:00Z,2022-01-04T04:59:59Z,2021-11-05T01:00:49Z,2021-24068,0,0,0900006484e17dd7
FDA-2021-D-0775-0001,FDA,FDA-2021-D-0775,"Content of Premarket Submissions for Device Software Functions; Draft
Guidance for Industry and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2021-11-04T04:00:00Z,2021,11,2021-11-04T04:00:00Z,2022-02-03T04:59:59Z,2022-03-11T02:00:35Z,2021-24061,0,0,0900006484e17ebe
FDA-2021-N-1112-0001,FDA,FDA-2021-N-1112,"Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealer’s Certificate and Other Records
Related to Participation in the National Shellfish Sanitation Program",Notice,60 Day Proposed Information Collection,2021-11-04T04:00:00Z,2021,11,2021-11-04T04:00:00Z,2022-01-04T04:59:59Z,2021-11-05T17:46:24Z,2021-24063,0,0,0900006484e1804a
FDA-2020-E-1333-0006,FDA,FDA-2020-E-1333,"Determination of Regulatory Review Period for Purposes of Patent
Extension; ADAKVEO",Notice,Determinations,2021-11-04T04:00:00Z,2021,11,2021-11-04T04:00:00Z,2022-01-04T04:59:59Z,2021-11-09T19:41:11Z,2021-24070,0,0,0900006484e1b47a
FDA-2020-E-1326-0006,FDA,FDA-2020-E-1326,"Determination of Regulatory Review Period for Purposes of Patent
Extension; SCENESSE",Notice,Determinations,2021-11-04T04:00:00Z,2021,11,2021-11-04T04:00:00Z,2022-01-04T04:59:59Z,2021-11-09T19:37:30Z,2021-24074,0,0,0900006484e17e82
FDA-2020-E-2124-0006,FDA,FDA-2020-E-2124,"Determination of Regulatory Review
Period for Purposes of Patent
Extension; SEVENFACT",Notice,Determinations,2021-11-04T04:00:00Z,2021,11,2021-11-04T04:00:00Z,2022-01-04T04:59:59Z,2021-11-04T16:26:46Z,2021-24065,0,0,0900006484e17f12
FDA-2020-E-2052-0006,FDA,FDA-2020-E-2052,Determination of Regulatory Review Period for Purposes of Patent Extension; AKLIEF,Notice,Determinations,2021-11-04T04:00:00Z,2021,11,2021-11-04T04:00:00Z,2022-01-04T04:59:59Z,2021-11-05T17:50:38Z,2021-24077,0,0,0900006484e1808a
FDA-2019-E-5390-0005,FDA,FDA-2019-E-5390,"Determination of Regulatory Review Period for Purposes of Patent
Extension; DENGVAXIA",Notice,Determinations,2021-11-04T04:00:00Z,2021,11,2021-11-04T04:00:00Z,2022-01-04T04:59:59Z,2021-11-09T18:03:44Z,2021-24067,0,0,0900006484e18016