documents
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822 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2021 sorted by posted_date descending
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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards 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 | Drugs Containing Anticholinergic/Antispasmodic Combination 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 | Notice to Industry on the Development of a Web-Based System for Obtaining a User Fee Payment Identification Number and Prescription Drug User Fee Cover Sheet (FDA Form 3397) 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 | Sunscreen Drug Products -OPEN 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 | Debar Sanyasi Kalidindi; Notice Opportunity for Hearing 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 | Certification for exporting products from the United States 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 |
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