documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
- comment_end_date
- A FULL UTC INSTANT, not a calendar date, despite the column name: '2026-08-29T03:59:59Z' is 11:59:59 PM EASTERN on 2026-08-28. Federal comment periods close at 11:59:59 PM Eastern, so the UTC calendar date is ONE DAY LATER than the official deadline on every end-of-day close — 444,689 of the 444,690 populated rows (measured 2026-09-06). Convert to America/New_York before presenting a deadline, and compare with julianday(comment_end_date) > julianday('now'): a plain > datetime('now') is a TEXT comparison between two different formats and keeps already-closed dockets matching for up to ~20 hours. The sibling column on open_comments.documents WAS corrected to an Eastern calendar date (queue #498); this one is unchanged and still an instant — the two databases do not agree on grain. (queue #644)
- comment_start_date
- A FULL UTC INSTANT, not a calendar date, despite the column name — same grain as comment_end_date on this table. Convert to America/New_York before presenting it. (queue #644)
20,143 rows where agency_id = "FDA" and document_type = "Notice" sorted by posted_date descending
This data as json, CSV (advanced)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-N-0004-0002 | FDA | Notice of Availability when we issue Emergency Use Authorizations (EUAs) for New World Screwworm FDA-2026-N-0004 | Authorization of Emergency Use for Four Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability | Notice | Notice of Availability | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T17:36:31Z | 2026-21084 | 0 | 0 | 09000064b967171d | |
| FDA-2026-N-1832-0079 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1344 - Part 1 of 2 - L-theanine (chemically synthesized) | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:36:14Z | 0 | 0 | 09000064b966c808 | ||
| FDA-2026-N-1832-0074 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1339 - L-ergothioneine produced by Escherichia coli EG38, expressing enzymes from Mycolicibacterium smegmatis, Schizophyllum commune H4-8, and Claviceps purpurea | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:35:17Z | 0 | 0 | 09000064b966cc7d | ||
| FDA-2026-N-1832-0075 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1340 - L-ergothioneine produced by Escherichia coli K12 MG1655, expressing enzymes from Mycolicibacterium smegmatis, Methylobacterium pseudosasicola, Microcoleus sp. PCC 7713, and Neurospora crassa | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:35:21Z | 0 | 0 | 09000064b966cc7e | ||
| FDA-2026-N-1832-0087 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1350 - Part 2 of 2 - Rebaudioside M produced by enzymatic treatment of rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:38:34Z | 0 | 0 | 09000064b966cc86 | ||
| FDA-2026-N-1832-0072 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1337 - Heat-killed Lacticaseibacillus paracasei 327 | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:35:01Z | 0 | 0 | 09000064b966cc7b | ||
| FDA-2026-N-1832-0078 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1343 - L-ergothioneine produced by Escherichia coli CGMCC 24897, expressing enzymes from Trichoderma reesei ATCC 13631 | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:35:55Z | 0 | 0 | 09000064b966cc81 | ||
| FDA-2026-N-1832-0080 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1344 - Part 2 of 2 - L-theanine (chemically synthesized) | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:36:19Z | 0 | 0 | 09000064b966ecd9 | ||
| FDA-2026-N-1832-0076 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1341 - Alternansucrase enzyme preparation produced by Escherichia coli expressing a gene encoding an alternansucrase enzyme from Leuconostoc mesenteroides | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:35:39Z | 0 | 0 | 09000064b966cc7f | ||
| FDA-2026-N-1832-0077 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1342 - D-psicose | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:35:51Z | 0 | 0 | 09000064b966cc80 | ||
| FDA-2026-N-1832-0085 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1349 - Polysorbate 65 | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:38:20Z | 0 | 0 | 09000064b966cc84 | ||
| FDA-2026-N-1832-0092 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1355 - Rebaudioside M9 produced by enzymatic treatment of rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:39:12Z | 0 | 0 | 09000064b966cc8a | ||
| FDA-2026-N-1832-0081 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1345 - Bacillus subtilis NCIMB 30283 | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:36:49Z | 0 | 0 | 09000064b966ecda | ||
| FDA-2026-N-1832-0090 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1353 - L-ergothioneine produced by Escherichia coli strain ERG2201 expressing genes encoding enzymes from Methylobacterium aquaticum, Trichoderma reesei, and Mycolicibacterium smegmatis | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:39:04Z | 0 | 0 | 09000064b966ecde | ||
| FDA-2026-N-1832-0094 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1358 - Lacticaseibacillus paracasei subsp. paracasei GDMCC 60960 | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:40:24Z | 0 | 0 | 09000064b966ece0 | ||
| FDA-2026-N-1832-0091 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1354 - Rebaudioside M produced by enzymatic treatment of rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:39:08Z | 0 | 0 | 09000064b966cc89 | ||
| FDA-2026-N-1832-0082 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1346 - Saccharomyces pastorianus “BY-1198” expressing a gene encoding an α-acetolactate decarboxylase enzyme from Acetobacter aceti | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:37:29Z | 0 | 0 | 09000064b966ecdb | ||
| FDA-2026-N-1832-0093 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1357 - Yeast protein produced by a non-genetically engineered Saccharomyces cerevisiae strain | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:40:20Z | 0 | 0 | 09000064b966ecdf | ||
| FDA-2026-N-1832-0084 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1348 - β-casein protein preparation | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:37:52Z | 0 | 0 | 09000064b966cc83 | ||
| FDA-2026-N-1832-0086 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1350 - Part 1 of 2 - Rebaudioside M produced by enzymatic treatment of rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:38:29Z | 0 | 0 | 09000064b966cc85 | ||
| FDA-2026-N-1832-0089 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1352 - 6-phytase enzyme preparation produced by Trichoderma reesei expressing a gene encoding 6-phytase from Escherichia coli | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:38:55Z | 0 | 0 | 09000064b966ecdc | ||
| FDA-2026-N-11624-0001 | FDA | Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee FDA-2026-N-11624 | Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee (TPSAC) | Notice | Request for Nominations | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T16:58:08Z | 2026-21027 | 0 | 0 | 09000064b9671769 | |
| FDA-2026-N-1832-0073 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1338 - Brazzein preparation produced by a genetically engineered strain of Komagataella phaffii “BG12” expressing a gene encoding for brazzein from Pentadiplandra brazzeana | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:35:05Z | 0 | 0 | 09000064b966cc7c | ||
| FDA-2026-N-1832-0083 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1347 - Lactobacillus plantarum KCTC 13101BP | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:37:49Z | 0 | 0 | 09000064b966cc82 | ||
| FDA-2026-N-1832-0088 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1351 - Heat-killed biomass of Xanthobacter sp. DSM 34079 | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:38:48Z | 0 | 0 | 09000064b966cc87 | ||
| FDA-2026-N-1832-0095 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1359 - Bifidobacterium animalis subsp. lactis CCTCC M 2013336 | Notice | General Notice | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:40:33Z | 0 | 0 | 09000064b966ece1 | ||
| FDA-2026-N-0008-0017 | FDA | Advisory Committee FDA-2026-N-0008 | Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory Committee; Renewal | Notice | Notice of Renewal | 2026-10-14T04:00:00Z | 2026 | 10 | 2026-10-14T04:00:00Z | 2026-10-14T18:23:42Z | 2026-20989 | 0 | 0 | 09000064b966b003 | |
| FDA-2026-N-7131-0008 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements FDA-2026-N-7131 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements | Notice | 30 Day Proposed Information Collection | 2026-10-14T04:00:00Z | 2026 | 10 | 2026-10-14T04:00:00Z | 2026-11-14T04:59:59Z | 2026-10-14T18:28:35Z | 2026-20980 | 1 | 0 | 09000064b966affd |
| FDA-2026-N-6739-0004 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Requirements and Facility Registration and Cosmetic Product Listing Program FDA-2026-N-6739 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Cosmetic Products | Notice | 30 Day Proposed Information Collection | 2026-10-14T04:00:00Z | 2026 | 10 | 2026-10-14T04:00:00Z | 2026-11-14T04:59:59Z | 2026-10-14T18:20:53Z | 2026-20990 | 1 | 0 | 09000064b966b085 |
| FDA-2026-N-7338-0003 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards FDA-2026-N-7338 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards | Notice | 30 Day Proposed Information Collection | 2026-10-14T04:00:00Z | 2026 | 10 | 2026-10-14T04:00:00Z | 2026-11-14T04:59:59Z | 2026-10-14T19:15:47Z | 2026-20981 | 1 | 0 | 09000064b966aeb3 |
| FDA-2024-D-2581-0010 | FDA | Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industry; Availability FDA-2024-D-2581 | Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability | Notice | Notice of Availability | 2026-10-13T04:00:00Z | 2026 | 10 | 2026-10-13T04:00:00Z | 2026-10-13T20:18:36Z | 2026-20817 | 0 | 0 | 09000064b965c59f | |
| FDA-2026-N-10835-0001 | FDA | Par Health USA LLC, U.S. Agent for PH Health Limited et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications FDA-2026-N-10835 | Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications | Notice | Withdrawal | 2026-10-09T04:00:00Z | 2026 | 10 | 2026-10-09T04:00:00Z | 2026-10-09T18:48:57Z | 2026-20762 | 0 | 0 | 09000064b96576b4 | |
| FDA-2026-N-7426-0003 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Use FDA-2026-N-7426 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use | Notice | 30 Day Proposed Information Collection | 2026-10-09T04:00:00Z | 2026 | 10 | 2026-10-09T04:00:00Z | 2026-11-10T04:59:59Z | 2026-10-09T18:12:21Z | 2026-20765 | 1 | 0 | 09000064b96577e0 |
| FDA-2014-N-0053-1398 | 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 | Notice | Public Meetings | 2026-10-09T04:00:00Z | 2026 | 10 | 2026-10-09T04:00:00Z | 2026-12-07T04:59:59Z | 2026-10-09T18:53:04Z | 2026-20720 | 1 | 0 | 09000064b9653e73 |
| FDA-2026-N-10786-0001 | FDA | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZANVASTRO (zilganersen) FDA-2026-N-10786 | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZANVASTRO (Zilganersen) | Notice | Announcement | 2026-10-09T04:00:00Z | 2026 | 10 | 2026-10-09T04:00:00Z | 2026-10-09T18:42:00Z | 2026-20769 | 0 | 0 | 09000064b9657707 | |
| FDA-2026-N-5816-0002 | 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; Correction | Notice | Correction | 2026-10-09T04:00:00Z | 2026 | 10 | 2026-10-09T04:00:00Z | 2026-10-09T18:36:17Z | 2026-20730 | 0 | 0 | 09000064b965774f | |
| FDA-2020-E-1882-0005 | FDA | Patent Term Extension Application for MONOFERRIC (ferric derisomaltose), Patent No. 8,815,301 FDA-2020-E-1882 | Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC | Notice | Determinations | 2026-10-09T04:00:00Z | 2026 | 10 | 2026-10-09T04:00:00Z | 2026-12-09T04:59:59Z | 2026-10-09T18:22:03Z | 2026-20766 | 1 | 0 | 09000064b9657798 |
| FDA-2026-N-10396-0001 | FDA | Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams FDA-2026-N-10396 | Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams | Notice | Withdrawal | 2026-10-09T04:00:00Z | 2026 | 10 | 2026-10-09T04:00:00Z | 2026-10-09T18:15:50Z | 2026-20758 | 0 | 0 | 09000064b965779c | |
| FDA-2026-P-4567-0004 | FDA | Requests that the FDA determine whether the Reference Listed Drug (RLD) LASIX ORAL SOLUTION, 10 mg/mL; New Drug Application (NDA) 017688 of SANOFI AVENTIS US LLC has been voluntarily withdrawn from sale for safety or efficacy reasons. FDA-2026-P-4567 | Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2026-10-09T04:00:00Z | 2026 | 10 | 2026-10-09T04:00:00Z | 2026-10-09T17:53:11Z | 2026-20764 | 0 | 0 | 09000064b96577e3 | |
| FDA-2026-N-6667-0002 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications (BLAs) FDA-2026-N-6667 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements | Notice | 30 Day Proposed Information Collection | 2026-10-09T04:00:00Z | 2026 | 10 | 2026-10-09T04:00:00Z | 2026-11-10T04:59:59Z | 2026-10-10T09:00:59Z | 2026-20768 | 1 | 0 | 09000064b9657794 |
| FDA-2020-E-1892-0005 | FDA | Patent Term Extension Application for MONOFERRIC (ferric derisomaltose), Patent No. 10,414,831 FDA-2020-E-1892 | Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC | Notice | Determinations | 2026-10-09T04:00:00Z | 2026 | 10 | 2026-10-09T04:00:00Z | 2026-12-09T04:59:59Z | 2026-10-09T18:23:55Z | 2026-20766 | 1 | 0 | 09000064b965705e |
| FDA-2026-N-7129-0005 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun)) FDA-2026-N-7129 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun)) | Notice | 30 Day Proposed Information Collection | 2026-10-08T04:00:00Z | 2026 | 10 | 2026-10-08T04:00:00Z | 2026-11-10T04:59:59Z | 2026-10-08T17:19:42Z | 2026-20661 | 1 | 0 | 09000064b9651f14 |
| FDA-2026-N-10605-0001 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations FDA-2026-N-10605 | Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations | Notice | 60 Day Proposed Information Collection | 2026-10-08T04:00:00Z | 2026 | 10 | 2026-10-08T04:00:00Z | 2026-12-08T04:59:59Z | 2026-10-08T17:22:43Z | 2026-20663 | 1 | 0 | 09000064b9651d3d |
| FDA-2022-P-0558-0005 | FDA | Requests that the FDA to determine if the Reference Listed Drug (RLD), OXANDRIN (oxandrolone tablets, USP) 2.5 mg and 10 mg, NDA 013718 owned by Gemini Laboratories LLC was voluntarily withdrawn from sale for reasons of safety or effectiveness to facilitate the approval of generic version. FDA-2022-P-0558 | Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction | Notice | Correction | 2026-10-07T04:00:00Z | 2026 | 10 | 2026-10-07T04:00:00Z | 2026-10-07T18:02:12Z | 2026-20503 | 0 | 0 | 09000064b96482e9 | |
| FDA-2026-N-11259-0001 | FDA | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; FAYUVI (rebisufligene etisparvovec-hopf) FDA-2026-N-11259 | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; FAYUVI (rebisufligene etisparvovechopf) | Notice | Announcement | 2026-10-06T04:00:00Z | 2026 | 10 | 2026-10-06T04:00:00Z | 2026-10-06T18:28:00Z | 2026-20434 | 0 | 0 | 09000064b962e73a | |
| FDA-2026-P-3632-0007 | FDA | Requests that the FDA to determine that PRALIDOXIME CHLORIDE (AUTOINJECTOR) 600 mg/2 mL intramuscular solution, (NDA 018986) from Meridian Medical Technologies Inc. was not discontinued or withdrawn due to safety or efficacy reasons. FDA-2026-P-3632 | Determination PRALIDOXIME CHLORIDE (Autoinjector) (Pralidoxime Chloride) Solution, 600 Milligrams/2 Milliliters (300 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2026-10-06T04:00:00Z | 2026 | 10 | 2026-10-06T04:00:00Z | 2026-10-06T18:37:10Z | 2026-20442 | 0 | 0 | 09000064b962e6a8 | |
| FDA-2026-N-4291-0002 | 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; Correction | Notice | Correction | 2026-10-06T04:00:00Z | 2026 | 10 | 2026-10-06T04:00:00Z | 2026-10-06T18:38:22Z | 2026-20460 | 0 | 0 | 09000064b962e6a7 | |
| FDA-2026-N-10429-0001 | FDA | Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information FDA-2026-N-10429 | Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information | Notice | Requests for Information (RFI) | 2026-10-06T04:00:00Z | 2026 | 10 | 2026-10-06T04:00:00Z | 2026-11-21T04:59:59Z | 2026-10-15T09:00:40Z | 2026-20427 | 1 | 0 | 09000064b962e7b9 |
| FDA-2025-N-1927-0104 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2024 FDA-2025-N-1927 | GRAS Notice (GRN) 1241 – Amendments – beta-lactoglobulin produced by Aspergillus oryzae | Notice | General Notice | 2026-10-02T04:00:00Z | 2026 | 10 | 2026-10-02T04:00:00Z | 2026-10-02T23:48:52Z | 0 | 0 | 09000064b95fccd7 | ||
| FDA-2025-N-1928-0079 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1251 – Amendment – Saccharomyces cerevisiae expressing a gene encoding a cysteine-thiol lyase from Staphylococcus hominis (S. cerevisiae "OYR-290") | Notice | General Notice | 2026-10-02T04:00:00Z | 2026 | 10 | 2026-10-02T04:00:00Z | 2026-10-02T23:49:37Z | 0 | 0 | 09000064b95fccda | ||
| FDA-2025-N-1927-0103 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2024 FDA-2025-N-1927 | GRAS Notice (GRN) 1237 – Amendment – beta-glucanase enzyme preparation produced by Talaromyces versatilis | Notice | General Notice | 2026-10-02T04:00:00Z | 2026 | 10 | 2026-10-02T04:00:00Z | 2026-10-02T23:48:16Z | 0 | 0 | 09000064b95fccd6 | ||
| FDA-2025-N-1928-0080 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2025 FDA-2025-N-1928 | GRAS Notice (GRN) 1252 – Amendments – Saccharomyces cerevisiae "BY-1568" | Notice | General Notice | 2026-10-02T04:00:00Z | 2026 | 10 | 2026-10-02T04:00:00Z | 2026-10-02T23:49:59Z | 0 | 0 | 09000064b95fccdb | ||
| FDA-2026-N-6876-0005 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Voluntary Improvement Program FDA-2026-N-6876 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Improvement Program | Notice | 30 Day Proposed Information Collection | 2026-10-01T04:00:00Z | 2026 | 10 | 2026-10-01T04:00:00Z | 2026-11-03T04:59:59Z | 2026-10-01T17:10:26Z | 2026-20085 | 1 | 0 | 09000064b95fa835 |
| FDA-2026-N-0008-0014 | FDA | Advisory Committee FDA-2026-N-0008 | Request for Nominations for Individuals and Consumer Organizations for Advisory Committees | Notice | Request for Nominations | 2026-10-01T04:00:00Z | 2026 | 10 | 2026-10-01T04:00:00Z | 2026-10-01T17:17:08Z | 2026-20065 | 0 | 0 | 09000064b95fa717 | |
| FDA-2026-N-0008-0016 | FDA | Advisory Committee FDA-2026-N-0008 | Request for Nominations for Voting Members of Food and Drug Administration Advisory Committees | Notice | Request for Nominations | 2026-10-01T04:00:00Z | 2026 | 10 | 2026-10-01T04:00:00Z | 2026-10-01T17:22:06Z | 2026-20063 | 0 | 0 | 09000064b95f234b | |
| FDA-2026-N-0008-0015 | FDA | Advisory Committee FDA-2026-N-0008 | Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal | Notice | Notice of Renewal | 2026-10-01T04:00:00Z | 2026 | 10 | 2026-10-01T04:00:00Z | 2026-10-01T17:19:17Z | 2026-20142 | 0 | 0 | 09000064b95fa69a | |
| FDA-2026-N-0008-0013 | FDA | Advisory Committee FDA-2026-N-0008 | Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal | Notice | Notice of Renewal | 2026-10-01T04:00:00Z | 2026 | 10 | 2026-10-01T04:00:00Z | 2026-10-01T17:14:19Z | 2026-20141 | 0 | 0 | 09000064b95fa7f1 | |
| FDA-2026-P-4574-0003 | FDA | Requests that the FDA determine whether the original formulation submitted for the Reference Listed Drng (RLD), ISTURSIA (osilodrostat) tablets 10 mg (Product Number 003); New Drug Application (NDA) 212801, held by RECORDATI RARE DISEASES INC has been voluntarily withdrawn from the commercial market or withdrawn from sale for reasons of safety or eff FDA-2026-P-4574 | Determination That ISTURISA (Osilodrostat) Tablets, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2026-09-30T04:00:00Z | 2026 | 9 | 2026-09-30T04:00:00Z | 2026-09-30T20:10:10Z | 2026-19968 | 0 | 0 | 09000064b95f22ff | |
| FDA-2026-N-10132-0001 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects and Institutional Review Boards FDA-2026-N-10132 | Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects and Institutional Review Boards | Notice | 60 Day Proposed Information Collection | 2026-09-29T04:00:00Z | 2026 | 9 | 2026-09-29T04:00:00Z | 2026-12-01T04:59:59Z | 2026-09-29T17:15:35Z | 2026-19849 | 1 | 0 | 09000064b95e7083 |
| FDA-2025-P-0394-0004 | FDA | Request that FDA determine whether the Reference Listed Drug (RLD), Sulfadiazine Tablets, 500 mg under New Drug Application (NDA) 004122 held by Eli Lilly and Co., was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons. FDA-2025-P-0394 | Determination That SULFADIAZINE (Sulfadiazine) Tablet, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2026-09-29T04:00:00Z | 2026 | 9 | 2026-09-29T04:00:00Z | 2026-09-29T17:20:40Z | 2026-19921 | 0 | 0 | 09000064b95e707d | |
| FDA-2026-N-2743-0003 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 FDA-2026-N-2743 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 | Notice | 30 Day Proposed Information Collection | 2026-09-29T04:00:00Z | 2026 | 9 | 2026-09-29T04:00:00Z | 2026-10-30T03:59:59Z | 2026-09-29T17:13:03Z | 2026-19850 | 1 | 0 | 09000064b95e920c |
| FDA-2026-N-10505-0001 | FDA | FHTA LLC; Withdrawal of Approval of New Drug Application for Mysoline (Primidone) Suspension, 250 Milligrams/5 Milliliters FDA-2026-N-10505 | FHTA LLC; Withdrawal of Approval of New Drug Application for MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters | Notice | Withdrawal | 2026-09-29T04:00:00Z | 2026 | 9 | 2026-09-29T04:00:00Z | 2026-09-29T17:09:02Z | 2026-19912 | 0 | 0 | 09000064b95e92f9 | |
| FDA-2025-N-6692-0002 | FDA | NOOH Proposal to Debar Jeffrey Thies FDA-2025-N-6692 | Jeffrey Thies: Final Debarment Order | Notice | Statutory Debarment | 2026-09-25T04:00:00Z | 2026 | 9 | 2026-09-25T04:00:00Z | 2026-09-25T22:46:01Z | 2026-19655 | 1 | 0 | 09000064b95c54e1 | |
| FDA-2026-N-9505-0001 | FDA | Robotically-Assisted Surgical Devices – Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability FDA-2026-N-9505 | Robotically-Assisted Surgical Devices—Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | Notice of Availability | 2026-09-25T04:00:00Z | 2026 | 9 | 2026-09-25T04:00:00Z | 2026-11-25T04:59:59Z | 2026-09-25T19:21:13Z | 2026-19704 | 1 | 0 | 09000064b95c549b |
| FDA-2026-N-10606-0001 | FDA | Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—New Drug Application (NDA) 219694 for atropine sulfate ophthalmic solution, 0.01% FDA-2026-N-10606 | Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—New Drug Application (NDA) 219694 for Atropine Sulfate Ophthalmic Solution, 0.01% | Notice | Request for Comments | 2026-09-25T04:00:00Z | 2026 | 9 | 2026-09-25T04:00:00Z | 2026-10-30T03:59:59Z | 2026-10-15T09:00:38Z | 2026-19700 | 1 | 0 | 09000064b95c540b |
| FDA-2026-C-10597-0001 | FDA | Filing of Color Additive Petition from Doehler GmbH; Request to Amend the Color Additive Regulations to Provide for the Safe Use of Calcium Sulfate in Various Foods at Levels Consistent with Good Manufacturing Practice FDA-2026-C-10597 | Filing of Color Additive Petition From Doehler GmbH; Request To Amend the Color Additive Regulations To Provide for the Safe Use of Calcium Sulfate in Various Foods at Levels Consistent With Good Manufacturing Practice | Notice | Announcement | 2026-09-25T04:00:00Z | 2026 | 9 | 2026-09-25T04:00:00Z | 2026-10-02T21:57:29Z | 2026-19658 | 0 | 0 | 09000064b95c6531 | |
| FDA-2025-N-7395-0002 | FDA | Proposal to Debar Naveed Aslam FDA-2025-N-7395 | Naveed Aslam: Final Debarment Order | Notice | Statutory Debarment | 2026-09-25T04:00:00Z | 2026 | 9 | 2026-09-25T04:00:00Z | 2026-09-25T20:59:18Z | 2026-19654 | 1 | 0 | 09000064b95c6607 | |
| FDA-2015-N-3326-0056 | FDA | Biosimilar User Fee Act FDA-2015-N-3326 | Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments | Notice | Request for Comments | 2026-09-25T04:00:00Z | 2026 | 9 | 2026-09-25T04:00:00Z | 2026-11-26T04:59:59Z | 2026-10-06T09:00:35Z | 2026-19660 | 1 | 0 | 09000064b95c53b7 |
| FDA-2026-N-10738-0001 | FDA | Improving patient access to deceased donor islet cells and cell products; Request for Information FDA-2026-N-10738 | Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information | Notice | Requests for Information (RFI) | 2026-09-24T04:00:00Z | 2026 | 9 | 2026-09-24T04:00:00Z | 2026-11-10T04:59:59Z | 2026-10-15T09:00:37Z | 2026-19563 | 1 | 0 | 09000064b95b6b07 |
| FDA-2026-N-1832-0071 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1328 – Amendment – beta-carotene produced by Yarrowia lipolytica CGMCC No. 33926 expressing genes from Mucor circinelloides and Y. lipolytica | Notice | General Notice | 2026-09-24T04:00:00Z | 2026 | 9 | 2026-09-24T04:00:00Z | 2026-09-24T21:54:19Z | 0 | 0 | 09000064b95bff68 | ||
| FDA-2026-N-1832-0068 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1302 – Amendments – Fermented grape pomace | Notice | General Notice | 2026-09-24T04:00:00Z | 2026 | 9 | 2026-09-24T04:00:00Z | 2026-09-24T21:54:02Z | 0 | 0 | 09000064b95bff61 | ||
| FDA-2026-N-1832-0069 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1311 – Amendments – L-theanine produced by Escherichia coli CICC 11189s | Notice | General Notice | 2026-09-24T04:00:00Z | 2026 | 9 | 2026-09-24T04:00:00Z | 2026-09-24T21:54:07Z | 0 | 0 | 09000064b95bff65 | ||
| FDA-2026-N-1832-0070 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1317 – Amendment – Bifidobacterium animalis subsp. lactis CGMCC18610 | Notice | General Notice | 2026-09-24T04:00:00Z | 2026 | 9 | 2026-09-24T04:00:00Z | 2026-09-24T21:54:13Z | 0 | 0 | 09000064b95bff66 | ||
| FDA-2026-N-4019-0002 | FDA | Proposal to Debar Sanjay Kumar FDA-2026-N-4019 | Sanjay Kumar: Final Debarment Order | Notice | Statutory Debarment | 2026-09-23T04:00:00Z | 2026 | 9 | 2026-09-23T04:00:00Z | 2026-09-23T17:51:10Z | 2026-19419 | 0 | 0 | 09000064b95b6abc | |
| FDA-2026-N-1832-0062 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1331 - Phospholipase A1 enzyme preparation produced by Fusarium commune | Notice | General Notice | 2026-09-23T04:00:00Z | 2026 | 9 | 2026-09-23T04:00:00Z | 2026-09-24T00:08:41Z | 0 | 0 | 09000064b95b8d00 | ||
| FDA-2026-N-1832-0060 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1326 - 5-D-keto-fructose | Notice | General Notice | 2026-09-23T04:00:00Z | 2026 | 9 | 2026-09-23T04:00:00Z | 2026-09-24T00:08:28Z | 0 | 0 | 09000064b95b5cfe | ||
| FDA-2026-N-1832-0061 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1330 - Mycodulcein preparation produced by Komagataella phaffii DSM 35637 expressing a gene encoding for mycodulcein from Mattirolomyces terfezioides | Notice | General Notice | 2026-09-23T04:00:00Z | 2026 | 9 | 2026-09-23T04:00:00Z | 2026-09-24T00:08:36Z | 0 | 0 | 09000064b95b5cff | ||
| FDA-2026-N-1832-0065 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1334 - Aggregated bovine plasma protein | Notice | General Notice | 2026-09-23T04:00:00Z | 2026 | 9 | 2026-09-23T04:00:00Z | 2026-09-24T00:08:57Z | 0 | 0 | 09000064b95b8d07 | ||
| FDA-2026-N-1832-0063 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1332 - Chymosin enzyme preparation produced by Kluyveromyces lactis expressing a gene encoding chymosin from Bos taurus | Notice | General Notice | 2026-09-23T04:00:00Z | 2026 | 9 | 2026-09-23T04:00:00Z | 2026-09-24T00:08:46Z | 0 | 0 | 09000064b95b8d01 | ||
| FDA-2026-N-1832-0066 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1335 - Maltogenic amylase enzyme preparation produced by Escherichia coli expressing a gene encoding maltogenic amylase from Geobacillus stearothermophilus | Notice | General Notice | 2026-09-23T04:00:00Z | 2026 | 9 | 2026-09-23T04:00:00Z | 2026-09-24T00:09:02Z | 0 | 0 | 09000064b95b8d36 | ||
| FDA-2026-N-1832-0064 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1333 - Maize cob extract | Notice | General Notice | 2026-09-23T04:00:00Z | 2026 | 9 | 2026-09-23T04:00:00Z | 2026-09-24T00:08:52Z | 0 | 0 | 09000064b95b8d04 | ||
| FDA-2026-N-1832-0067 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1336 - Lactiplantibacillus plantarum CGMCC 13008 | Notice | General Notice | 2026-09-23T04:00:00Z | 2026 | 9 | 2026-09-23T04:00:00Z | 2026-09-24T00:09:08Z | 0 | 0 | 09000064b95b8d37 | ||
| FDA-2026-N-1832-0057 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1313 - Amendments - Algal oil (≥35% docosahexaenoic acid) from Schizochytrium limacinum CCAP A2 | Notice | General Notice | 2026-09-22T04:00:00Z | 2026 | 9 | 2026-09-22T04:00:00Z | 2026-09-22T16:04:18Z | 0 | 0 | 09000064b9592377 | ||
| FDA-2026-N-1832-0059 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1321 - Amendments - A powder prepared from the dried leaves and stems of the Geraldton waxflower (Chamelaucium uncinatum) | Notice | General Notice | 2026-09-22T04:00:00Z | 2026 | 9 | 2026-09-22T04:00:00Z | 2026-09-22T16:05:50Z | 0 | 0 | 09000064b9595955 | ||
| FDA-2026-N-1832-0056 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1308 - Amendments - β-glucan produced by Kluyveromyces marxianus CGMCC 26703 | Notice | General Notice | 2026-09-22T04:00:00Z | 2026 | 9 | 2026-09-22T04:00:00Z | 2026-09-22T16:03:58Z | 0 | 0 | 09000064b9592376 | ||
| FDA-2026-N-1832-0058 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1318 - Amendment - Steviol Glycosides consisting primarily of Rebaudioside M and Rebaudioside D | Notice | General Notice | 2026-09-22T04:00:00Z | 2026 | 9 | 2026-09-22T04:00:00Z | 2026-09-22T16:05:18Z | 0 | 0 | 09000064b9595954 | ||
| FDA-2022-N-2396-0014 | FDA | Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement. FDA-2022-N-2396 | Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement | Notice | Announcement | 2026-09-21T04:00:00Z | 2026 | 9 | 2026-09-21T04:00:00Z | 2026-09-21T17:24:09Z | 2026-19277 | 0 | 0 | 09000064b959db2f | |
| FDA-2026-N-10033-0001 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 FDA-2026-N-10033 | Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | Notice | 60 Day Proposed Information Collection | 2026-09-21T04:00:00Z | 2026 | 9 | 2026-09-21T04:00:00Z | 2026-11-21T04:59:59Z | 2026-09-22T09:00:47Z | 2026-19281 | 1 | 0 | 09000064b959dbae |
| FDA-2026-N-10430-0001 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption from Preemption FDA-2026-N-10430 | Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption | Notice | 60 Day Proposed Information Collection | 2026-09-21T04:00:00Z | 2026 | 9 | 2026-09-21T04:00:00Z | 2026-11-21T04:59:59Z | 2026-09-21T17:21:17Z | 2026-19282 | 1 | 0 | 09000064b959db5f |
| FDA-2026-N-3400-0003 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs FDA-2026-N-3400 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs | Notice | 30 Day Proposed Information Collection | 2026-09-21T04:00:00Z | 2026 | 9 | 2026-09-21T04:00:00Z | 2026-10-22T03:59:59Z | 2026-09-21T17:09:16Z | 2026-19284 | 1 | 0 | 09000064b959dbaf |
| FDA-2026-N-10363-0001 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications FDA-2026-N-10363 | Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications | Notice | 60 Day Proposed Information Collection | 2026-09-21T04:00:00Z | 2026 | 9 | 2026-09-21T04:00:00Z | 2026-11-21T04:59:59Z | 2026-09-21T17:16:01Z | 2026-19283 | 1 | 0 | 09000064b959db67 |
| FDA-2026-D-9429-0001 | FDA | Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability FDA-2026-D-9429 | Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | Notice of Availability | 2026-09-18T04:00:00Z | 2026 | 9 | 2026-09-18T04:00:00Z | 2026-11-18T04:59:59Z | 2026-09-18T18:00:19Z | 2026-19181 | 1 | 0 | 09000064b958f5ee |
| FDA-2025-N-2787-0007 | FDA | Advancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Comments FDA-2025-N-2787 | Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document | Notice | Notice of Availability | 2026-09-18T04:00:00Z | 2026 | 9 | 2026-09-18T04:00:00Z | 2026-11-18T04:59:59Z | 2026-09-18T18:37:52Z | 2026-19166 | 1 | 0 | 09000064b958ecea |
| FDA-2026-D-7233-0001 | FDA | Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availability FDA-2026-D-7233 | Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2026-09-18T04:00:00Z | 2026 | 9 | 2026-09-18T04:00:00Z | 2026-11-18T04:59:59Z | 2026-09-18T18:09:09Z | 2026-19141 | 1 | 0 | 09000064b958f536 |
| FDA-2024-D-2732-0013 | FDA | Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Draft Guidance FDA-2024-D-2732 | Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Guidance for Industry; Availability | Notice | Notice of Availability | 2026-09-17T04:00:00Z | 2026 | 9 | 2026-09-17T04:00:00Z | 2026-09-17T17:37:38Z | 2026-19080 | 0 | 0 | 09000064b957e418 | |
| FDA-2026-N-8692-0001 | FDA | Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments --- Pathogen-agnostic sequencing FDA-2026-N-8692 | Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Pathogen-Agnostic Sequencing | Notice | Request for Comments | 2026-09-16T04:00:00Z | 2026 | 9 | 2026-09-16T04:00:00Z | 2026-11-13T04:59:59Z | 2026-10-04T09:00:20Z | 2026-18920 | 1 | 0 | 09000064b956b6a9 |
| FDA-2026-N-0027-0003 | FDA | Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing. FDA-2026-N-0027 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing | Notice | 30 Day Proposed Information Collection | 2026-09-16T04:00:00Z | 2026 | 9 | 2026-09-16T04:00:00Z | 2026-10-17T03:59:59Z | 2026-09-16T17:00:39Z | 2026-18946 | 1 | 0 | 09000064b956b6ef |
| FDA-2026-N-1832-0054 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1328 - β-carotene derived from recombinant Yarrowia lipolytica | Notice | General Notice | 2026-09-15T04:00:00Z | 2026 | 9 | 2026-09-15T04:00:00Z | 2026-09-15T15:13:44Z | 0 | 0 | 09000064b9554839 | ||
| FDA-2026-N-1832-0055 | FDA | Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 | GRAS Notice (GRN) 1329 - Lactase enzyme preparation produced by Aspergillus oryzae | Notice | General Notice | 2026-09-15T04:00:00Z | 2026 | 9 | 2026-09-15T04:00:00Z | 2026-09-15T15:13:49Z | 0 | 0 | 09000064b9554f00 | ||
| FDA-2026-N-10165-0001 | FDA | Statistical Considerations for Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments FDA-2026-N-10165 | Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments | Notice | Request for Comments | 2026-09-15T04:00:00Z | 2026 | 9 | 2026-09-15T04:00:00Z | 2026-11-14T04:59:59Z | 2026-09-16T09:00:44Z | 2026-18805 | 1 | 0 | 09000064b955afbc |
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CREATE TABLE documents (
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agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
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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;