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827 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2022 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-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| FDA-2022-D-3054 | M11 Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Guidance for Industry; Draft Template; and Technical Specification; Availability | Notice | Notice of Availability | 2022-12-22T05:00:00Z | 2022 | 12 |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| FDA-2014-D-1167-0024 | FDA | FDA-2014-D-1167 | Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2022-12-22T05:00:00Z | 2022 | 12 | 2022-12-22T13:50:27Z | 2022-27827 | 0 | 0 | 090000648554d546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 | Microbial Effects of Antimicrobial New Animal Drugs/Human Safety 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 | Recommendations for Donor Questioning Regarding Malaria 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 | Statistical Approaches Establishing Bioequivalence 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 |
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id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
subtype TEXT,
posted_date TEXT,
posted_year INTEGER,
posted_month INTEGER,
comment_start_date TEXT,
comment_end_date TEXT,
last_modified TEXT,
fr_doc_num TEXT,
open_for_comment INTEGER,
withdrawn INTEGER,
object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);