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19,805 rows where agency_id = "FDA" and document_type = "Notice" 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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| FDA-2026-D-2698-0001 | FDA | Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability FDA-2026-D-2698 | Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2026-06-15T04:00:00Z | 2026 | 6 | 2026-06-15T17:12:16Z | 2026-11966 | 0 | 0 | 09000064b932f27d | ||
| FDA-2026-N-0809-0040 | FDA | Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments. FDA-2026-N-0809 | Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period | Notice | Request for Comments | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-03-04T04:59:59Z | 2026-06-11T17:12:02Z | 2026-11690 | 0 | 0 | 09000064b9324b04 |
| FDA-2026-N-0498-0002 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products FDA-2026-N-0498 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products | Notice | 30 Day Proposed Information Collection | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-07-14T03:59:59Z | 2026-06-11T17:38:55Z | 2026-11762 | 1 | 0 | 09000064b93249f6 |
| FDA-2025-N-4250-0003 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods FDA-2025-N-4250 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods | Notice | 30 Day Proposed Information Collection | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-07-14T03:59:59Z | 2026-06-11T17:33:35Z | 2026-11760 | 1 | 0 | 09000064b9324abc |
| FDA-2026-N-1832-0021 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1312 - Recombinant αs1-Casein from Bos taurus produced by E. coli (αs1-cn) | Notice | General Notice | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-11T22:59:48Z | 0 | 0 | 09000064b9323675 | ||
| FDA-2026-N-1832-0024 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1315 - Short-chain chondroitin sulfate oligosaccharides produced from enzymatic hydrolysis of chondroitin sulfate | Notice | General Notice | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-11T23:00:22Z | 0 | 0 | 09000064b93244f7 | ||
| FDA-2026-N-4492-0206 | FDA | Drug Repurposing for Unmet Medical Needs; Request for Information FDA-2026-N-4492 | Drug Repurposing for Unmet Medical Needs; Request for Information; Extension of Comment Period | Notice | Extension of Comment Period | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-11T17:43:54Z | 2026-11691 | 0 | 0 | 09000064b93249b7 | |
| FDA-2026-N-1832-0023 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1314 - Bacillus pumilus SG154 Strain | Notice | General Notice | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-11T23:00:15Z | 0 | 0 | 09000064b93244f6 | ||
| FDA-2026-N-1832-0022 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1313 - DHA-rich oil from Schizochytrium limacinum A2 | Notice | General Notice | 2026-06-11T04:00:00Z | 2026 | 6 | 2026-06-11T04:00:00Z | 2026-06-11T22:59:53Z | 0 | 0 | 09000064b9323676 | ||
| FDA-2025-N-6494-0050 | FDA | Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use FDA-2025-N-6494 | Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information | Notice | Announcement | 2026-06-10T04:00:00Z | 2026 | 6 | 2026-06-10T04:00:00Z | 2026-06-10T21:18:04Z | 2026-11578 | 0 | 0 | 09000064b93216d6 | |
| FDA-2026-N-5817-0001 | FDA | Determination That PROTAMINE SULFATE (Protamine Sulfate) Intravenous; Solution, 50 Milligrams/5 Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness FDA-2026-N-5817 | Determination That Protamine Sulfate (Protamine Sulfate) Intravenous; Solution, 50 Milligrams/5 Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2026-06-08T04:00:00Z | 2026 | 6 | 2026-06-08T16:51:28Z | 2026-11429 | 0 | 0 | 09000064b931b84b | ||
| FDA-2014-D-0967-0036 | FDA | Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements FDA-2014-D-0967 | Intent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | Notice of Availability | 2026-06-05T04:00:00Z | 2026 | 6 | 2026-06-05T04:00:00Z | 2026-06-05T17:22:43Z | 2026-11303 | 0 | 0 | 09000064b93158a7 | |
| FDA-2016-D-1307-0036 | FDA | Questions and Answers Regarding Drug and Device Manufacturer Communications with Payors; Draft Guidance for Industry; Availability FDA-2016-D-1307 | Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers; Revised Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2026-06-03T04:00:00Z | 2026 | 6 | 2026-06-03T04:00:00Z | 2026-06-03T18:20:20Z | 2026-11060 | 0 | 0 | 09000064b930af49 | |
| FDA-2026-N-5816-0001 | FDA | Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications FDA-2026-N-5816 | Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications | Notice | Withdrawal | 2026-06-03T04:00:00Z | 2026 | 6 | 2026-06-03T04:00:00Z | 2026-06-03T18:17:35Z | 2026-11062 | 0 | 0 | 09000064b930afcc | |
| FDA-2024-N-2602-0009 | FDA | First Annual Animal Drug User Fee Educational Conference; Public Meeting FDA-2024-N-2602 | Third Annual Animal Drug User Fee Educational Conference; Public Meeting | Notice | Meeting | 2026-06-03T04:00:00Z | 2026 | 6 | 2026-06-03T04:00:00Z | 2026-06-05T09:00:13Z | 2026-11101 | 1 | 0 | 09000064b930c159 | |
| FDA-2022-N-2390-0669 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Vanda Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon) | Notice | Hearings | 2026-06-03T04:00:00Z | 2026 | 6 | 2026-06-03T04:00:00Z | 2026-07-07T03:59:59Z | 2026-06-03T17:59:58Z | 2026-11046 | 1 | 0 | 09000064b930c153 |
| FDA-2024-D-5580-0017 | FDA | M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Draft Guidance for Industry; Availability FDA-2024-D-5580 | M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Guidance for Industry; Availability | Notice | Notice of Availability | 2026-06-03T04:00:00Z | 2026 | 6 | 2026-06-03T04:00:00Z | 2026-06-03T18:07:07Z | 2026-11112 | 0 | 0 | 09000064b930b0fe | |
| FDA-2026-D-1257-0001 | FDA | Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability FDA-2026-D-1257 | Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2026-06-03T04:00:00Z | 2026 | 6 | 2026-06-03T04:00:00Z | 2026-06-03T17:32:48Z | 2026-11054 | 0 | 0 | 09000064b930c155 | |
| FDA-2026-D-2839-0001 | FDA | Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability FDA-2026-D-2839 | Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2026-06-01T04:00:00Z | 2026 | 6 | 2026-06-01T04:00:00Z | 2026-06-01T17:32:10Z | 2026-10873 | 0 | 0 | 09000064b9303ad2 | |
| FDA-2026-N-1832-0020 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1309 - D-psicose | Notice | General Notice | 2026-05-29T04:00:00Z | 2026 | 5 | 2026-05-29T04:00:00Z | 2026-05-29T15:58:58Z | 0 | 0 | 09000064b92f94a6 | ||
| FDA-2026-N-1832-0017 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1305 - Brazzein preparation produced by Komagataella phaffii GDMCC 70101 expressing a gene encoding for brazzein from Pentadiplandra brazzeana | Notice | General Notice | 2026-05-29T04:00:00Z | 2026 | 5 | 2026-05-29T04:00:00Z | 2026-05-29T15:57:49Z | 0 | 0 | 09000064b92f94a0 | ||
| FDA-2026-N-0008-0007 | FDA | Advisory Committee FDA-2026-N-0008 | Advisory Committee; Psychopharmacologic Drugs Advisory Committee; Renewal | Notice | Notice of Renewal | 2026-05-29T04:00:00Z | 2026 | 5 | 2026-05-29T04:00:00Z | 2026-05-29T17:13:43Z | 2026-10674 | 0 | 0 | 09000064b92fcfad | |
| FDA-2026-N-5057-0001 | FDA | Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments FDA-2026-N-5057 | Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments | Notice | Request for Comments | 2026-05-29T04:00:00Z | 2026 | 5 | 2026-05-29T04:00:00Z | 2026-10-27T03:59:59Z | 2026-05-29T17:21:31Z | 2026-10752 | 1 | 0 | 09000064b92fcf66 |
| FDA-2015-D-4599-0037 | FDA | List of Highest Priority Devices for Human Factors Review FDA-2015-D-4599 | Content of Human Factors Information in Medical Device Marketing Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | Notice of Availability | 2026-05-29T04:00:00Z | 2026 | 5 | 2026-05-29T04:00:00Z | 2026-05-29T17:24:08Z | 2026-10734 | 0 | 0 | 09000064b92fcd07 | |
| FDA-2013-D-1464-0022 | FDA | Draft Guidance for Industry on Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted under an ANDA; Availability FDA-2013-D-1464 | Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Guidance for Industry; Availability | Notice | Notice of Availability | 2026-05-29T04:00:00Z | 2026 | 5 | 2026-05-29T04:00:00Z | 2026-05-29T17:16:39Z | 2026-10703 | 0 | 0 | 09000064b92fcf69 | |
| FDA-2026-N-1832-0019 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1308 - Betaglucan produced by Kluyveromyces marxianus CGMCC 26703 | Notice | General Notice | 2026-05-29T04:00:00Z | 2026 | 5 | 2026-05-29T04:00:00Z | 2026-05-29T15:58:36Z | 0 | 0 | 09000064b92f94a5 | ||
| FDA-2026-N-1832-0018 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1307 - Rebaudioside M produced by enzymatic treatment of steviol glycosides purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni | Notice | General Notice | 2026-05-29T04:00:00Z | 2026 | 5 | 2026-05-29T04:00:00Z | 2026-05-29T15:58:17Z | 0 | 0 | 09000064b92f94a1 | ||
| FDA-2001-D-0197-0020 | FDA | Statistical Approaches Establishing Bioequivalence FDA-2001-D-0197 | Statistical Approaches To Establishing Bioequivalence; Guidance for Industry; Availability | Notice | Notice of Availability | 2026-05-29T04:00:00Z | 2026 | 5 | 2026-05-29T04:00:00Z | 2026-05-29T17:47:18Z | 2026-10705 | 0 | 0 | 09000064b92fcb6a | |
| FDA-2026-N-4390-0048 | FDA | AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information FDA-2026-N-4390 | AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period | Notice | Extension of Comment Period | 2026-05-28T04:00:00Z | 2026 | 5 | 2026-05-28T04:00:00Z | 2026-05-28T17:26:35Z | 2026-10602 | 0 | 0 | 09000064b92f8788 | |
| FDA-2014-N-0053-1369 | FDA | Designation of High-Risk Foods for Tracing; Request for Comments and for Scientific Data and Information FDA-2014-N-0053 | Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments | Notice | Request for Comments | 2026-05-28T04:00:00Z | 2026 | 5 | 2026-05-28T04:00:00Z | 2026-07-16T03:59:59Z | 2026-06-12T09:00:30Z | 2026-10603 | 1 | 0 | 09000064b92f8854 |
| FDA-1998-P-0083-0013 | FDA | Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 | Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661 | Notice | Withdrawal | 2026-05-27T04:00:00Z | 2026 | 5 | 2026-05-27T17:28:51Z | 2026-10479 | 0 | 0 | 09000064b92f3c99 | ||
| FDA-2026-N-0008-0006 | FDA | Advisory Committee FDA-2026-N-0008 | Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal | Notice | Notice of Renewal | 2026-05-26T04:00:00Z | 2026 | 5 | 2026-05-26T16:53:05Z | 2026-10371 | 0 | 0 | 09000064b92f0633 | ||
| FDA-2026-N-5128-0001 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act FDA-2026-N-5128 | Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act | Notice | 60 Day Proposed Information Collection | 2026-05-26T04:00:00Z | 2026 | 5 | 2026-05-26T04:00:00Z | 2026-07-28T03:59:59Z | 2026-05-26T16:54:54Z | 2026-10372 | 1 | 0 | 09000064b92f05ee |
| FDA-2026-N-0008-0005 | FDA | Advisory Committee FDA-2026-N-0008 | Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee; Renewal | Notice | Notice of Renewal | 2026-05-26T04:00:00Z | 2026 | 5 | 2026-05-26T16:52:52Z | 2026-10410 | 0 | 0 | 09000064b92f06c5 | ||
| FDA-2026-N-4162-0001 | FDA | Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments - Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) manufactured by Moderna TX Inc. FDA-2026-N-4162 | Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) Manufactured by Moderna TX Inc. | Notice | Request for Comments | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-06-18T03:59:59Z | 2026-06-15T09:00:18Z | 2026-10321 | 1 | 0 | 09000064b92ecd0e |
| FDA-2007-D-0369-2531 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability | Notice | Notice of Availability | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-05-22T17:26:17Z | 2026-10277 | 0 | 0 | 09000064b92ecd58 | |
| FDA-2022-D-3054-0036 | FDA | M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Draft Guidance for Industry; Draft Template; and Technical Specification; Availability FDA-2022-D-3054 | M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability | Notice | Notice of Availability | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-05-22T18:37:34Z | 2026-10295 | 0 | 0 | 09000064b92ec40f | |
| FDA-2008-N-0567-0198 | FDA | Designating Additions to the Current List of Tropical Diseases in Section 1102 of the Food and Drug Administration Amendments Act FDA-2008-N-0567 | Notice of Decision Not To Designate Hepatitis Delta Virus Diseases as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act | Notice | General Notice | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-05-26T21:16:59Z | 2026-10268 | 1 | 0 | 09000064b92ecd55 | |
| FDA-2022-D-2424-0012 | FDA | Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request FDA-2022-D-2424 | Protein Efficiency Ratio Rat Bioassay Studies To Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Guidance for Industry; Availability | Notice | Notice of Availability | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-05-22T19:00:07Z | 2026-10284 | 0 | 0 | 09000064b92ec387 | |
| FDA-2026-N-0497-0002 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions FDA-2026-N-0497 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions | Notice | 30 Day Proposed Information Collection | 2026-05-21T04:00:00Z | 2026 | 5 | 2026-05-21T04:00:00Z | 2026-06-23T03:59:59Z | 2026-05-21T17:10:24Z | 2026-10190 | 1 | 0 | 09000064b92e83b1 |
| FDA-2026-N-1303-0002 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Events Associated With New Animal Drugs FDA-2026-N-1303 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events With Approved New Animal Drugs | Notice | 30 Day Proposed Information Collection | 2026-05-21T04:00:00Z | 2026 | 5 | 2026-05-21T04:00:00Z | 2026-06-23T03:59:59Z | 2026-05-21T17:05:09Z | 2026-10189 | 1 | 0 | 09000064b92e83b8 |
| FDA-2026-N-0746-0005 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program FDA-2026-N-0746 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program | Notice | 30 Day Proposed Information Collection | 2026-05-21T04:00:00Z | 2026 | 5 | 2026-05-21T04:00:00Z | 2026-06-23T03:59:59Z | 2026-05-21T16:54:56Z | 2026-10188 | 1 | 0 | 09000064b92e8437 |
| FDA-2025-N-6076-0004 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Required Warnings for Cigarette Packages and Advertisements FDA-2025-N-6076 | Agency Information Collection Activities; Proposals, Submissions, and Approvals: Required Warnings for Cigarette Packages and Advertisements | Notice | 30 Day Proposed Information Collection | 2026-05-21T04:00:00Z | 2026 | 5 | 2026-05-21T04:00:00Z | 2026-06-23T03:59:59Z | 2026-05-21T20:57:01Z | 2026-10187 | 1 | 0 | 09000064b92e9178 |
| FDA-2026-N-1832-0016 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1294 – Rebaudioside M produced by enzymatic treatment of steviol glycosides purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni – amendments | Notice | General Notice | 2026-05-19T04:00:00Z | 2026 | 5 | 2026-05-19T04:00:00Z | 2026-05-19T22:46:40Z | 0 | 0 | 09000064b92e1248 | ||
| FDA-2025-N-1928-0070 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1250 - Alternansucrase enzyme preparation produced by Escherichia coli expressing the gene encoding alternansucrase from Leuconostoc mesenteroides - amendments | Notice | General Notice | 2026-05-19T04:00:00Z | 2026 | 5 | 2026-05-19T04:00:00Z | 2026-05-19T22:44:43Z | 0 | 0 | 09000064b92e1210 | ||
| FDA-2025-N-1928-0076 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1272 - Lacto-N-neotetraose - amendments | Notice | General Notice | 2026-05-19T04:00:00Z | 2026 | 5 | 2026-05-19T04:00:00Z | 2026-05-19T22:45:48Z | 0 | 0 | 09000064b92e122d | ||
| FDA-2025-N-1928-0071 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1253 - Lycopene preparation produced by Saccharomyces cerevisiae JZL03 - amendment | Notice | General Notice | 2026-05-19T04:00:00Z | 2026 | 5 | 2026-05-19T04:00:00Z | 2026-05-19T22:45:19Z | 0 | 0 | 09000064b92e1212 | ||
| FDA-2025-N-1928-0074 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1262 - 2'-Fucosyllactose - amendments | Notice | General Notice | 2026-05-19T04:00:00Z | 2026 | 5 | 2026-05-19T04:00:00Z | 2026-05-19T22:45:37Z | 0 | 0 | 09000064b92e1218 | ||
| FDA-2025-N-1928-0073 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1258 - Lacto-N-tetraose - amendments | Notice | General Notice | 2026-05-19T04:00:00Z | 2026 | 5 | 2026-05-19T04:00:00Z | 2026-05-19T22:45:32Z | 0 | 0 | 09000064b92e1216 | ||
| FDA-2025-N-1928-0077 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1273 - Lacto-N-tetraose - amendments | Notice | General Notice | 2026-05-19T04:00:00Z | 2026 | 5 | 2026-05-19T04:00:00Z | 2026-05-19T22:45:54Z | 0 | 0 | 09000064b92e122f | ||
| FDA-2025-N-1928-0075 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1263 - Bacillus coagulans PTA-127366 spore preparation - amendment | Notice | General Notice | 2026-05-19T04:00:00Z | 2026 | 5 | 2026-05-19T04:00:00Z | 2026-05-19T22:45:42Z | 0 | 0 | 09000064b92e122b | ||
| FDA-2025-N-1928-0078 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1292 - Citrus-derived compounded sweetener made with neohesperidin dihydrochalcone and gamma cyclodextrin - amendments | Notice | General Notice | 2026-05-19T04:00:00Z | 2026 | 5 | 2026-05-19T04:00:00Z | 2026-05-19T22:45:59Z | 0 | 0 | 09000064b92e1231 | ||
| FDA-2025-N-1928-0072 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1257 - 2’-Fucosyllactose - amendments | Notice | General Notice | 2026-05-19T04:00:00Z | 2026 | 5 | 2026-05-19T04:00:00Z | 2026-05-19T22:45:26Z | 0 | 0 | 09000064b92e1214 | ||
| FDA-2025-N-0421-0002 | FDA | NOOH Proposal to Debar Oscar Bobo FDA-2025-N-0421 | Oscar Bobo: Final Debarment Order | Notice | Statutory Debarment | 2026-05-15T04:00:00Z | 2026 | 5 | 2026-05-15T04:00:00Z | 2026-05-15T17:48:54Z | 2026-09767 | 1 | 0 | 09000064b92da9bd | |
| FDA-2026-N-4126-0001 | FDA | Azodicarbonamide (ADA); Request for Information FDA-2026-N-4126 | Azodicarbonamide (ADA); Request for Information | Notice | Requests for Information (RFI) | 2026-05-13T04:00:00Z | 2026 | 5 | 2026-05-13T04:00:00Z | 2026-07-14T03:59:59Z | 2026-05-13T17:13:38Z | 2026-09508 | 1 | 0 | 09000064b92d17fd |
| FDA-2026-N-3098-0001 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting FDA-2026-N-3098 | Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting | Notice | 60 Day Proposed Information Collection | 2026-05-13T04:00:00Z | 2026 | 5 | 2026-05-13T04:00:00Z | 2026-07-14T03:59:59Z | 2026-05-13T16:56:28Z | 2026-09543 | 1 | 0 | 09000064b92d4966 |
| FDA-2019-N-0994-0230 | FDA | Modified Risk Tobacco Product Applications for VLN™ King and VLN™ Menthol King, Combusted, Filtered Cigarettes, Submitted by 22nd Century Group Inc. FDA-2019-N-0994 | Modified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc. | Notice | Request for Comments | 2026-05-13T04:00:00Z | 2026 | 5 | 2026-05-13T04:00:00Z | 2026-05-27T09:00:28Z | 2026-09544 | 1 | 0 | 09000064b92d47df | |
| FDA-2026-N-2526-0001 | FDA | Butylated hydroxytoluene (BHT); Request for Information FDA-2026-N-2526 | Butylated Hydroxytoluene (BHT); Request for Information | Notice | Requests for Information (RFI) | 2026-05-13T04:00:00Z | 2026 | 5 | 2026-05-13T04:00:00Z | 2026-07-14T03:59:59Z | 2026-05-28T09:00:18Z | 2026-09507 | 1 | 0 | 09000064b92d4931 |
| FDA-2025-N-1600-0003 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3 FDA-2025-N-1600 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3 | Notice | 30 Day Proposed Information Collection | 2026-05-13T04:00:00Z | 2026 | 5 | 2026-05-13T04:00:00Z | 2026-06-13T03:59:59Z | 2026-05-13T17:17:21Z | 2026-09448 | 0 | 0 | 09000064b92d4828 |
| FDA-2026-N-0005-0001 | FDA | Public Seminar FDA-2026-N-0005 | Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information | Notice | Requests for Information (RFI) | 2026-05-13T04:00:00Z | 2026 | 5 | 2026-05-13T04:00:00Z | 2026-07-14T03:59:59Z | 2026-05-20T09:00:17Z | 2026-09533 | 1 | 0 | 09000064b92d48f3 |
| FDA-2026-N-4492-0001 | FDA | Drug Repurposing for Unmet Medical Needs; Request for Information FDA-2026-N-4492 | Drug Repurposing for Unmet Medical Needs; Request for Information | Notice | Requests for Information (RFI) | 2026-05-12T04:00:00Z | 2026 | 5 | 2026-05-12T04:00:00Z | 2026-07-14T03:59:59Z | 2026-06-15T09:00:15Z | 2026-09366 | 1 | 0 | 09000064b92d15f4 |
| FDA-2017-N-5925-0040 | FDA | Standard Development Organizations Whose Susceptibility Test Interpretive Criteria Standards May Be Recognized by FDA FDA-2017-N-5925 | 21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria web page | Notice | Request for Comments | 2026-05-12T04:00:00Z | 2026 | 5 | 2026-05-12T04:00:00Z | 2026-05-12T22:58:36Z | 2026-09438 | 1 | 0 | 09000064b92d17af | |
| FDA-2026-D-5083-0001 | FDA | Enforcement Policies for Certain Electronic Nicotine Delivery Systems (ENDS) Marketed Without Premarket Authorization; Guidance for Industry; Availability FDA-2026-D-5083 | Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry; Availability | Notice | Notice of Availability | 2026-05-12T04:00:00Z | 2026 | 5 | 2026-05-12T04:00:00Z | 2026-05-12T17:17:05Z | 2026-09368 | 0 | 0 | 09000064b92d1762 | |
| FDA-2025-N-2220-0002 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications On Medical Devices and Radiation-Emitting Products FDA-2025-N-2220 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications On Medical Devices and Radiation-Emitting Products | Notice | 30 Day Proposed Information Collection | 2026-05-11T04:00:00Z | 2026 | 5 | 2026-05-11T04:00:00Z | 2026-06-11T03:59:59Z | 2026-06-11T09:00:16Z | 2026-09244 | 0 | 0 | 09000064b92cfa18 |
| FDA-2011-N-0655-0042 | FDA | Animal Generic Drug User Fee Act; Public Meeting FDA-2011-N-0655 | Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate | Notice | Notice of Intent | 2026-05-11T04:00:00Z | 2026 | 5 | 2026-05-11T04:00:00Z | 2026-05-11T21:26:21Z | 2026-09284 | 0 | 0 | 09000064b92cf91b | |
| FDA-2026-N-4573-0001 | FDA | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; AVLAYAH (tividenofusp alfa-eknm) FDA-2026-N-4573 | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; AVLAYAH (tividenofusp alfa-eknm) | Notice | Announcement | 2026-05-11T04:00:00Z | 2026 | 5 | 2026-05-11T04:00:00Z | 2026-05-11T17:34:15Z | 2026-09242 | 0 | 0 | 09000064b92cf987 | |
| FDA-2013-D-1319-0015 | FDA | Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability FDA-2013-D-1319 | Pulmonary Tuberculosis: Developing Drugs for Treatment; Guidance for Industry; Availability | Notice | Notice of Availability | 2026-05-11T04:00:00Z | 2026 | 5 | 2026-05-11T04:00:00Z | 2026-05-11T17:27:37Z | 2026-09269 | 0 | 0 | 09000064b92cf98a | |
| FDA-2018-D-4693-0022 | FDA | Postapproval Pregnancy Safety Studies; Draft Guidance for Industry; Availability FDA-2018-D-4693 | Postapproval Pregnancy Safety Studies; Guidance for Industry; Availability | Notice | Notice of Availability | 2026-05-11T04:00:00Z | 2026 | 5 | 2026-05-11T04:00:00Z | 2026-05-11T17:36:17Z | 2026-09268 | 0 | 0 | 09000064b92cf982 | |
| FDA-2011-N-0656-1315 | FDA | Animal Drug User Fee Act; Public Meeting FDA-2011-N-0656 | Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate | Notice | General Notice | 2026-05-11T04:00:00Z | 2026 | 5 | 2026-05-11T04:00:00Z | 2026-05-11T17:56:32Z | 2026-09283 | 0 | 0 | 09000064b92cacd0 | |
| FDA-2022-D-1261-0003 | FDA | Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention; Draft Guidance for Industry; Availability FDA-2022-D-1261 | Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention; Guidance for Industry; Availability | Notice | Notice of Availability | 2026-05-11T04:00:00Z | 2026 | 5 | 2026-05-11T04:00:00Z | 2026-05-11T17:42:11Z | 2026-09267 | 0 | 0 | 09000064b92cf922 | |
| FDA-2026-P-0749-0004 | FDA | Requests that the FDA determine whether Leucovorin Calcium For Oral Solution, EQ 60 mg base/vial, (NDA 008107) held by Hospira Inc. has been voluntarily withdrawn or withheld from sale for reasons of safety or efficacy FDA-2026-P-0749 | Determination That Leucovorin Calcium, Oral Solution, Equivalent to 60 Milligrams Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2026-05-08T04:00:00Z | 2026 | 5 | 2026-05-08T17:04:13Z | 2026-09199 | 0 | 0 | 09000064b92c97d0 | ||
| FDA-2025-P-7054-0006 | FDA | Request that the FDA determine whether the Reference Listed Drug (RLD) MICARDIS (Telmisartan Tablets, 20 mg and 80 mg) under New Drug Application (NDA) N020850 held by Boehringer Ingelheim, was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons FDA-2025-P-7054 | Determination That MICARDIS (Telmisartan), Tablets, 20 Milligrams and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2026-05-07T04:00:00Z | 2026 | 5 | 2026-05-07T04:00:00Z | 2026-05-07T17:15:35Z | 2026-09011 | 0 | 0 | 09000064b92c66bf | |
| FDA-2023-D-2370-0007 | FDA | Patient-Matched Guides to Orthopedic Implants; Draft Guidance for Industry and Food and Drug Administration Staff; Draft Guidance for Industry and Food and Drug Administration Staff; Availability FDA-2023-D-2370 | Patient-Matched Guides for Orthopedic Implants; Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | Notice of Availability | 2026-05-07T04:00:00Z | 2026 | 5 | 2026-05-07T04:00:00Z | 2026-05-07T17:05:32Z | 2026-09023 | 0 | 0 | 09000064b92c78fc | |
| FDA-2026-N-4291-0001 | FDA | Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications FDA-2026-N-4291 | Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications | Notice | Withdrawal | 2026-05-07T04:00:00Z | 2026 | 5 | 2026-05-07T04:00:00Z | 2026-05-07T16:54:25Z | 2026-09012 | 0 | 0 | 09000064b92c85aa | |
| FDA-2026-N-0008-0004 | FDA | Advisory Committee FDA-2026-N-0008 | Advisory Committee; Blood Products Advisory Committee; Renewal | Notice | Notice of Renewal | 2026-05-07T04:00:00Z | 2026 | 5 | 2026-05-07T04:00:00Z | 2026-05-07T17:02:15Z | 2026-09108 | 0 | 0 | 09000064b92c85a3 | |
| FDA-2026-N-4588-0001 | FDA | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OTARMENI (lunsotogene parvec-cwha) FDA-2026-N-4588 | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OTARMENI (lunsotogene parvec-cwha) | Notice | Announcement | 2026-05-06T04:00:00Z | 2026 | 5 | 2026-05-06T04:00:00Z | 2026-05-06T17:40:41Z | 2026-08913 | 0 | 0 | 09000064b92c5bca | |
| FDA-2026-P-1306-0004 | FDA | Requests that the FDA to determine whether the Reference Listed Drug (RLD) DEXAMETHASONE ELIXIR, 0.5 mg/5 mL; Abbreviated New Drug Application (ANDA) 088254 of PHARMOBEDIENT CONSULTING has been voluntarily withdrawn from sale for safety or efficacy reasons. FDA-2026-P-1306 | Determination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2026-05-06T04:00:00Z | 2026 | 5 | 2026-05-06T04:00:00Z | 2026-05-06T17:34:01Z | 2026-08939 | 0 | 0 | 09000064b92c65a4 | |
| FDA-2026-N-3070-0001 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; National Youth Tobacco Survey FDA-2026-N-3070 | Agency Information Collection Activities; Proposed Collection; Comment Request; National Youth Tobacco Survey | Notice | 60 Day Proposed Information Collection | 2026-05-04T04:00:00Z | 2026 | 5 | 2026-05-04T04:00:00Z | 2026-07-07T03:59:59Z | 2026-05-04T19:19:25Z | 2026-08604 | 1 | 0 | 09000064b92c115c |
| FDA-2018-N-3240-0377 | FDA | List of Bulk Drug Substances For Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Notice 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 | Request for Comments | 2026-05-01T04:00:00Z | 2026 | 5 | 2026-05-01T04:00:00Z | 2026-07-01T03:59:59Z | 2026-06-15T09:00:13Z | 2026-08552 | 1 | 0 | 09000064b92bb724 |
| FDA-2026-N-3499-0001 | FDA | Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments FDA-2026-N-3499 | Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments | Notice | Request for Comments | 2026-05-01T04:00:00Z | 2026 | 5 | 2026-05-01T04:00:00Z | 2026-07-01T03:59:59Z | 2026-05-02T09:00:17Z | 2026-08521 | 1 | 0 | 09000064b92bb7fb |
| FDA-2026-N-3947-0001 | FDA | Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments FDA-2026-N-3947 | Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments | Notice | Request for Comments | 2026-05-01T04:00:00Z | 2026 | 5 | 2026-05-01T04:00:00Z | 2026-07-01T03:59:59Z | 2026-06-13T09:00:11Z | 2026-08524 | 1 | 0 | 09000064b92bb6d7 |
| FDA-2026-N-4268-0001 | FDA | Medical Devices; Exemptions from Premarket Notification: Certain Class II Devices; Request for Comments FDA-2026-N-4268 | Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments | Notice | Request for Comments | 2026-05-01T04:00:00Z | 2026 | 5 | 2026-05-01T04:00:00Z | 2026-07-01T03:59:59Z | 2026-06-13T09:00:11Z | 2026-08499 | 1 | 0 | 09000064b92bb7b3 |
| FDA-2026-N-0499-0002 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice FDA-2026-N-0499 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice | Notice | 30 Day Proposed Information Collection | 2026-04-30T04:00:00Z | 2026 | 4 | 2026-04-30T04:00:00Z | 2026-06-02T03:59:59Z | 2026-06-02T09:00:30Z | 2026-08417 | 0 | 0 | 09000064b92b80f2 |
| FDA-2026-P-0655-0003 | FDA | Request that the FDA determine that the listed RLD product FENOGLIDE (fenofibrate) Tablets, 40 mg and 120 mg, N022118, NDA Holder– Salix Pharmaceuticals INC, was not discontinued for safety or effectiveness reasons FDA-2026-P-0655 | Determination FENOGLIDE (Fenofibrate) Tablets, 40 Milligrams and 120 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2026-04-30T04:00:00Z | 2026 | 4 | 2026-04-30T17:56:39Z | 2026-08390 | 0 | 0 | 09000064b92b7f6c | ||
| FDA-2026-N-0008-0003 | FDA | Advisory Committee FDA-2026-N-0008 | Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal | Notice | Notice of Renewal | 2026-04-30T04:00:00Z | 2026 | 4 | 2026-04-30T18:03:08Z | 2026-08378 | 0 | 0 | 09000064b92b7f20 | ||
| FDA-2025-P-3849-0004 | FDA | Requests that the FDA determine whether OZEMPIC (semaglutide) Injection, 2 mg/1.5 mL (1.34 mg/mL) was withdrawn for safety or effectiveness reasons. FDA-2025-P-3849 | Determination That OZEMPIC (Semaglutide) Solution, 2 Milligrams Per 1.5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2026-04-30T04:00:00Z | 2026 | 4 | 2026-04-30T18:12:42Z | 2026-08435 | 0 | 0 | 09000064b92b5df8 | ||
| FDA-2026-N-3532-0001 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies FDA-2026-N-3532 | Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies | Notice | 60 Day Proposed Information Collection | 2026-04-30T04:00:00Z | 2026 | 4 | 2026-04-30T04:00:00Z | 2026-06-30T03:59:59Z | 2026-05-02T09:00:17Z | 2026-08371 | 1 | 0 | 09000064b92b7fb3 |
| FDA-2026-N-1321-0001 | FDA | ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing FDA-2026-N-1321 | ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing | Notice | Withdrawal | 2026-04-30T04:00:00Z | 2026 | 4 | 2026-04-30T04:00:00Z | 2026-06-30T03:59:59Z | 2026-06-12T09:00:26Z | 2026-08455 | 1 | 0 | 09000064b92b7e81 |
| FDA-2026-N-4390-0001 | FDA | AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information FDA-2026-N-4390 | AI-Enabled Optimization of Early- Phase Clinical Trials Pilot Program; Request for Information | Notice | Requests for Information (RFI) | 2026-04-29T04:00:00Z | 2026 | 4 | 2026-04-29T04:00:00Z | 2026-06-30T03:59:59Z | 2026-06-15T09:00:13Z | 2026-08281 | 1 | 0 | 09000064b92b54c8 |
| FDA-2026-N-1832-0014 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1303 - Bifidobacterium animalis subsp. lactis CGMCC5470 | Notice | General Notice | 2026-04-28T04:00:00Z | 2026 | 4 | 2026-04-28T04:00:00Z | 2026-04-28T16:29:48Z | 0 | 0 | 09000064b92a8cd6 | ||
| FDA-2025-N-1928-0067 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1279 – Saccharomyces cerevisiae CCTCC M2025194 – amendments | Notice | General Notice | 2026-04-28T04:00:00Z | 2026 | 4 | 2026-04-28T04:00:00Z | 2026-04-28T16:24:49Z | 0 | 0 | 09000064b92a80fa | ||
| FDA-2026-N-1832-0008 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1297 - Enzyme-hydrolyzed brown rice protein - Part 3 of 3 | Notice | General Notice | 2026-04-28T04:00:00Z | 2026 | 4 | 2026-04-28T04:00:00Z | 2026-04-28T16:28:45Z | 0 | 0 | 09000064b92a8ccc | ||
| FDA-2025-N-1928-0066 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1278 – Lactiplantibacillus plantarum CGMCC 6312 – amendments | Notice | General Notice | 2026-04-28T04:00:00Z | 2026 | 4 | 2026-04-28T04:00:00Z | 2026-04-28T16:24:47Z | 0 | 0 | 09000064b92a80f9 | ||
| FDA-2025-N-1928-0064 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1256 – Lemna leaf protein – amendments | Notice | General Notice | 2026-04-28T04:00:00Z | 2026 | 4 | 2026-04-28T04:00:00Z | 2026-04-28T16:18:46Z | 0 | 0 | 09000064b92a80f7 | ||
| FDA-2026-N-1832-0007 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1297 - Enzyme-hydrolyzed brown rice protein - Part 2 of 3 | Notice | General Notice | 2026-04-28T04:00:00Z | 2026 | 4 | 2026-04-28T04:00:00Z | 2026-04-28T16:28:26Z | 0 | 0 | 09000064b92a8ccb | ||
| FDA-2025-N-1928-0065 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1276 – Cellulase enzyme preparation produced by Trichoderma reesei expressing a gene encoding a cellulase from Aspergillus niger – amendments | Notice | General Notice | 2026-04-28T04:00:00Z | 2026 | 4 | 2026-04-28T04:00:00Z | 2026-04-28T16:24:37Z | 0 | 0 | 09000064b92a80f8 | ||
| FDA-2026-N-1832-0015 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1304 - Preparation containing at least three bacteriophages (phage) specific to Listeria spp. | Notice | General Notice | 2026-04-28T04:00:00Z | 2026 | 4 | 2026-04-28T04:00:00Z | 2026-04-28T16:29:52Z | 0 | 0 | 09000064b92a8cd7 | ||
| FDA-2026-N-1832-0003 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1293 - Brazzein preparation produced by Komagataella phaffii “RA-b” expressing a gene encoding for brazzein from Pentadiplandra brazzeana - Part 2 of 2 | Notice | General Notice | 2026-04-28T04:00:00Z | 2026 | 4 | 2026-04-28T04:00:00Z | 2026-04-28T16:27:02Z | 0 | 0 | 09000064b92a8cc6 | ||
| FDA-2026-N-1832-0005 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1295 - Brazzein preparation produced by Komagataella phaffii GS115 expressing a gene encoding for brazzein from Pentadiplandra brazzeana | Notice | General Notice | 2026-04-28T04:00:00Z | 2026 | 4 | 2026-04-28T04:00:00Z | 2026-04-28T16:27:45Z | 0 | 0 | 09000064b92a8cc9 | ||
| FDA-2025-N-1928-0069 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1296 - Erythritol produced through fermentation of glucose by Yarrowia lipolytica | Notice | General Notice | 2026-04-28T04:00:00Z | 2026 | 4 | 2026-04-28T04:00:00Z | 2026-04-28T16:25:01Z | 0 | 0 | 09000064b92a80fc |
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CREATE TABLE documents (
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);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;