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)
232,083 rows where agency_id = "FDA" sorted by posted_date descending
This data as json, CSV (advanced)
posted_year >30
- 2017 24,468
- 2016 18,435
- 2024 16,156
- 2019 15,939
- 2018 15,765
- 2025 15,077
- 2023 13,127
- 2026 13,102
- 2015 11,812
- 2022 11,533
- 2014 11,406
- 2020 9,522
- 2021 8,221
- 2013 7,453
- 2008 5,759
- 2009 5,314
- 2012 4,226
- 2011 3,966
- 2010 3,813
- 2004 3,116
- 2007 3,095
- 2003 2,853
- 2006 2,645
- 2005 2,474
- 2002 711
- 1996 448
- 2001 424
- 2000 325
- 1999 209
- 1997 200
- …
document_type 5
- Other 149,259
- Supporting & Related Material 59,746
- Notice 20,143
- Rule 1,768
- Proposed Rule 1,167
agency_id 1
- FDA · 232,083 ✖
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-P-12444-0009 | FDA | Request that the FDA Establish an Independent Heath Safety Investigation Board with Replay-Analysis Authority for Systemic Review of Regulatory Failures in the Oversight of Foods, Drugs, Biological Products, and Medical Devices FDA-2026-P-12444 | exhibit_4_draft_regulation_21_cfr_part_10_subpart_f | Supporting & Related Material | Background Material | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T19:17:19Z | 0 | 0 | 09000064b966d1ce | |||
| FDA-2026-H-12248-0001 | FDA | DAB Civil Money Penalty; Wawa Florida, LLC d/b/a Wawa 5497 FDA-2026-H-12248 | Complaint | Other | Complaint | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T20:07:35Z | 0 | 0 | 09000064b9671b11 | ||
| FDA-2026-S-0024-0712 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000789 - LifeSeasons - LifeSeasons, Children's Calm + Focus Chewables - Behavior Support | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:44:39Z | 0 | 0 | 09000064b966ae8e | ||
| FDA-2026-S-0024-0715 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000793 - Imana Health Inc - Muna oral probiotic - oral probiotic that supports vaginal health and immune function | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:45:00Z | 0 | 0 | 09000064b966e2e8 | ||
| FDA-2026-H-12245-0001 | FDA | DAB Civil Money Penalty; Dolgencorp, LLC d/b/a Dollar General 30967 FDA-2026-H-12245 | Complaint | Other | Complaint | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T21:43:36Z | 0 | 0 | 09000064b9671d17 | ||
| FDA-2026-H-12251-0001 | FDA | DAB Civil Money Penalty; Papo Mini Market LLC d/b/a Papo Mini Market LLC. FDA-2026-H-12251 | Complaint | Other | Complaint | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T22:09:38Z | 0 | 0 | 09000064b9671d4b | ||
| FDA-2026-S-0024-0736 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000790 - Nestle Health Science - Multiple Claims (6) | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:47:25Z | 0 | 0 | 09000064b966cb2c | ||
| FDA-2026-S-0024-0730 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000810 - Maharishi Ayurveda Products USA Inc - Multiple Claims (2) | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:46:29Z | 0 | 0 | 09000064b966cfbd | ||
| FDA-2026-S-0024-0723 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000801 - TSI USA LLC - Tailored Script, Gymnema sylvestre - supports glucose metabolism | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:45:51Z | 0 | 0 | 09000064b966d88c | ||
| FDA-2026-S-0024-0716 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000794 - Pharmavite LLC - Nature Made IRON + C & Bs capsules - C supports immune health & Bs support cellular energy | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:45:10Z | 0 | 0 | 09000064b966e2ea | ||
| FDA-2026-S-0024-0720 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000798 - TSI USA LLC - Tailored Script, Ginkgo Biloba - supports healthy circulation and blood flow | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:45:31Z | 0 | 0 | 09000064b966e2f2 | ||
| FDA-2026-S-0024-0726 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000804 - TSI USA LLC - Tailored Script, Calcium hydroxyapatite - Supports bone health Supports dental health Supports calcium supplementation | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:46:08Z | 0 | 0 | 09000064b966ea3d | ||
| FDA-2026-P-12607-0003 | FDA | Requests that the FDA declare that the drug product Diclofenac Sodium Topical Solution, 1.95%, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12607 | Attachment 1 | Supporting & Related Material | Background Material | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-16T00:48:07Z | 0 | 0 | 09000064b9671d1e | |||
| FDA-2026-P-12607-0005 | FDA | Requests that the FDA declare that the drug product Diclofenac Sodium Topical Solution, 1.95%, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12607 | Attachment 3 | Supporting & Related Material | Background Material | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-16T00:48:12Z | 0 | 0 | 09000064b9672ffb | |||
| FDA-2026-P-12607-0006 | FDA | Requests that the FDA declare that the drug product Diclofenac Sodium Topical Solution, 1.95%, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12607 | Attachment 4 | Supporting & Related Material | Background Material | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-16T00:48:15Z | 0 | 0 | 09000064b9672ffc | |||
| FDA-2026-V-11784-0002 | FDA | Laser Light Show FDA-2026-V-11784 | Acknowledgment Letter from FDA DMB to Connor Younge | Other | Acknowledgement Letter/Receipt | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T18:17:28Z | 0 | 0 | 09000064b961e3b5 | ||
| FDA-2026-V-11784-0003 | FDA | Laser Light Show FDA-2026-V-11784 | Variance Approval Letter to Connor Younge | Other | Approval for Variance (VRA) | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T18:17:32Z | 0 | 0 | 09000064b96692ab | ||
| 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-P-12447-0001 | FDA | Request that the FDA order manufacturers of all approved systemic fluroquinolone antibiotics (including ciprofloxacin, lavofloxacin, moxifloxacin, delafloxacin, and ofloxacin) to update their professional physician labeling and patient Medication Guides to achieve the following FDA-2026-P-12447 | Citizen Petition from Charles Bennett | Other | Citizen Petition | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:31:41Z | 1 | 0 | 09000064b966d233 | ||
| 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-S-0024-0729 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000809 - CanPrev Natural Health Products Ltd - B9 Folate (5-MTHF + B12) - helps to maintain healthy metabolism | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:46:24Z | 0 | 0 | 09000064b966cfbb | ||
| FDA-2026-S-0024-0724 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000802 - TSI USA LLC - Tailored Script, Chaste tree (Vitex agnus-castus) - supports female reproductive health | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:45:56Z | 0 | 0 | 09000064b966d88e | ||
| FDA-2026-S-0024-0727 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000805 - Infirst Healthcare Inc - Mylicon, Children's Mylicon Nighttime Tummy Relief + Sleep - Helps with occasional upset stomach | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:46:14Z | 0 | 0 | 09000064b966ea3f | ||
| FDA-2026-P-12607-0002 | FDA | Requests that the FDA declare that the drug product Diclofenac Sodium Topical Solution, 1.95%, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12607 | Acknowledgement Letter from FDA DMB to Hyman, Phelps & McNamara, P.C. | Other | Acknowledgement Letter/Receipt | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-16T00:48:03Z | 0 | 0 | 09000064b9672ff0 | ||
| FDA-2026-S-0024-0711 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000788 - LifeSeasons - LifeSeasons, Anxie-Teen Focus and Stress Chewables - Support occaisonal stress | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:44:34Z | 0 | 0 | 09000064b966ae8c | ||
| FDA-2026-H-12253-0001 | FDA | DAB Civil Money Penalty; Yafa Services Inc. d/b/a Dale Road Drive Thru FDA-2026-H-12253 | Complaint | Other | Complaint | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T21:09:54Z | 0 | 0 | 09000064b9671b21 | ||
| FDA-2026-H-12246-0001 | FDA | DAB Civil Money Penalty; Mama Enterprise LLC d/b/a Exxon / Food Mart FDA-2026-H-12246 | Complaint | Other | Complaint | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T21:41:24Z | 0 | 0 | 09000064b966e2f8 | ||
| FDA-2026-H-12252-0001 | FDA | DAB Civil Money Penalty; Catherine Store Ventures LLC, d/b/a Catherine Store / Shell FDA-2026-H-12252 | Complaint | Other | Complaint | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T22:14:12Z | 0 | 0 | 09000064b9671d5c | ||
| 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-P-12447-0002 | FDA | Request that the FDA order manufacturers of all approved systemic fluroquinolone antibiotics (including ciprofloxacin, lavofloxacin, moxifloxacin, delafloxacin, and ofloxacin) to update their professional physician labeling and patient Medication Guides to achieve the following FDA-2026-P-12447 | Acknowledgment Letter from FDA DOD to Charles Bennett | Other | Acknowledgement Letter/Receipt | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:31:45Z | 0 | 0 | 09000064b966d24a | ||
| 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-2011-D-0611-0105 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Questions and Answers on Biosimilar Development and the BPCI Act; Guidance for Industry | Other | Guidance | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:50:39Z | 1 | 0 | 09000064b9670307 | ||
| FDA-2026-V-11618-0001 | FDA | Laser Light Show FDA-2026-V-11618 | Variance Application from Ultimate Rush Floyd LLC | Other | Application for Variance (VAR) | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T18:20:20Z | 0 | 0 | 09000064b95fcba4 | ||
| FDA-2026-V-11784-0001 | FDA | Laser Light Show FDA-2026-V-11784 | Variance Application from Connor Younge | Other | Application for Variance (VAR) | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T18:17:25Z | 0 | 0 | 09000064b961e3b2 | ||
| FDA-2026-P-12444-0003 | FDA | Request that the FDA Establish an Independent Heath Safety Investigation Board with Replay-Analysis Authority for Systemic Review of Regulatory Failures in the Oversight of Foods, Drugs, Biological Products, and Medical Devices FDA-2026-P-12444 | Cover Letter | Supporting & Related Material | Background Material | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T19:17:00Z | 0 | 0 | 09000064b966d1ab | |||
| FDA-2026-P-12444-0010 | FDA | Request that the FDA Establish an Independent Heath Safety Investigation Board with Replay-Analysis Authority for Systemic Review of Regulatory Failures in the Oversight of Foods, Drugs, Biological Products, and Medical Devices FDA-2026-P-12444 | exhibit_5_congressional_investigation_findings | Supporting & Related Material | Background Material | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T19:17:22Z | 0 | 0 | 09000064b966d1d2 | |||
| FDA-2026-S-0024-0706 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000782 - Haleon - Benefober Daily Prebiotic Fiber Gummies Berry Citrus Splash - support an environment for good digestive health | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:44:11Z | 0 | 0 | 09000064b9658198 | ||
| FDA-2026-S-0024-0713 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000791 - Iovate Health Sciences International Inc - Multiple Claims (7) | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:44:48Z | 0 | 0 | 09000064b966cb2e | ||
| FDA-2026-S-0024-0719 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000797 - TSI USA LLC - Tailored Script, Tart Cherry - supports a healthy immune system | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:45:26Z | 0 | 0 | 09000064b966e2f0 | ||
| FDA-2026-S-0024-0734 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000814 - DOVITA NUTRITION HEALTH LLC - AIDEVI AKKERMANSIA 34 BILLION - METABOLIC BALANCE FORMULA | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:46:49Z | 0 | 0 | 09000064b966e671 | ||
| FDA-2026-S-0024-0728 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000808 - The Waterstreet Collective - Multiple Claims (4) | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:46:19Z | 0 | 0 | 09000064b966ea41 | ||
| FDA-2026-P-12607-0004 | FDA | Requests that the FDA declare that the drug product Diclofenac Sodium Topical Solution, 1.95%, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12607 | Attachment 2 | Supporting & Related Material | Background Material | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-16T00:48:09Z | 0 | 0 | 09000064b9671d1f | |||
| FDA-2026-P-12607-0001 | FDA | Requests that the FDA declare that the drug product Diclofenac Sodium Topical Solution, 1.95%, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12607 | Suitability Petition from Hyman, Phelps & McNamara, P.C. | Other | Petition(s) | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-16T00:47:59Z | 1 | 0 | 09000064b9672fea | ||
| FDA-2026-P-12444-0007 | FDA | Request that the FDA Establish an Independent Heath Safety Investigation Board with Replay-Analysis Authority for Systemic Review of Regulatory Failures in the Oversight of Foods, Drugs, Biological Products, and Medical Devices FDA-2026-P-12444 | exhibit_2_fda_regulatory_process_map | Supporting & Related Material | Background Material | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T19:17:13Z | 0 | 0 | 09000064b966d1be | |||
| 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-2022-V-2880-0004 | FDA | Laser Light Show FDA-2022-V-2880 | Variance Renewal from California Pro Sound and Light | Other | Application for Variance (VAR) | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:38:24Z | 0 | 0 | 09000064b9671aa1 | ||
| FDA-2022-V-2880-0005 | FDA | Laser Light Show FDA-2022-V-2880 | Variance Approval Letter from FDA CDRH to California Pro Sound And Light | Other | Acknowledgement Letter/Receipt | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:38:29Z | 0 | 0 | 09000064b9671aaa | ||
| FDA-2026-H-12250-0001 | FDA | DAB Civil Money Penalty; Vallabh Krupa Inc. d/b/a Pilgrim Liquors FDA-2026-H-12250 | Complaint | Other | Complaint | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T22:33:11Z | 0 | 0 | 09000064b9671c1c | ||
| FDA-2026-S-0024-0714 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000792 - Iovate Health Sciences International Inc - Multiple Claims (3) | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:44:55Z | 0 | 0 | 09000064b966e2e6 | ||
| FDA-2026-S-0024-0718 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000796 - Wella - Nioxin Pro Clinical Age Defense Supplement - promotes hair fullness and maintains hair color | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:45:19Z | 0 | 0 | 09000064b966e2ee | ||
| FDA-2026-S-0024-0731 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000811 - DOVITA NUTRITION HEALTH LLC - AIDEVI WHITE TOMATO WHITENING PRO - enhances skin elasticity | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:46:34Z | 0 | 0 | 09000064b966e66b | ||
| 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-P-12444-0002 | FDA | Request that the FDA Establish an Independent Heath Safety Investigation Board with Replay-Analysis Authority for Systemic Review of Regulatory Failures in the Oversight of Foods, Drugs, Biological Products, and Medical Devices FDA-2026-P-12444 | Acknowledgment Letter from FDA DOD to John Kelser | Other | Acknowledgement Letter/Receipt | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:16:51Z | 0 | 0 | 09000064b966d1a8 | ||
| FDA-2026-P-12444-0004 | FDA | Request that the FDA Establish an Independent Heath Safety Investigation Board with Replay-Analysis Authority for Systemic Review of Regulatory Failures in the Oversight of Foods, Drugs, Biological Products, and Medical Devices FDA-2026-P-12444 | cc_list_fda_citizen_petition_distribution | Supporting & Related Material | Background Material | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T19:17:04Z | 0 | 0 | 09000064b966d1b9 | |||
| FDA-2026-P-12444-0006 | FDA | Request that the FDA Establish an Independent Heath Safety Investigation Board with Replay-Analysis Authority for Systemic Review of Regulatory Failures in the Oversight of Foods, Drugs, Biological Products, and Medical Devices FDA-2026-P-12444 | exhibit_1_fda_regulatory_failure_map_1848_2026 | Supporting & Related Material | Background Material | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T19:17:10Z | 0 | 0 | 09000064b966d1bd | |||
| 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-V-11618-0002 | FDA | Laser Light Show FDA-2026-V-11618 | Acknowledgment Letter from FDA DMB to Ultimate Rush Floyd LLC | Other | Acknowledgement Letter/Receipt | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T18:20:24Z | 0 | 0 | 09000064b95fcba6 | ||
| FDA-2026-S-0024-0705 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000781 - Herb Pharm - Herb Pharm, Oil of Oregano - supports the immune system | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:44:06Z | 0 | 0 | 09000064b9653ed1 | ||
| FDA-2026-S-0024-0708 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000784 - Transformative Learning Pte Ltd - HERBUS, Shilajit - Support healthy Menopause | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:44:19Z | 0 | 0 | 09000064b96642a5 | ||
| FDA-2026-S-0024-0709 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000786 - Soi Health LLC - Soi Health, SO I DON'T BARF- fast- acting support for occasional stomach discomfort | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:44:23Z | 0 | 0 | 09000064b96642bc | ||
| FDA-2026-S-0024-0710 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000787 - LifeSeasons - LifeSeasons, Children's Eye + Brain Chewables - Learning Support | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:44:28Z | 0 | 0 | 09000064b9668ede | ||
| FDA-2026-S-0024-0722 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000800 - TSI US LLC - Tailored Script, St. John's Wort - supports mood | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:45:47Z | 0 | 0 | 09000064b966d88a | ||
| FDA-2026-S-0024-0725 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000803 - TSI USA LLC - Tailored Script, NMN (Nicotinamide mononucleotide) - Supports NAD+ metabolism | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:46:02Z | 0 | 0 | 09000064b966d890 | ||
| FDA-2026-S-0024-0717 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000795 - Pharmavite LLC - Nature Made NAD+ Booster capsules - increased NAD+ in blood cells vs placebo | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:45:15Z | 0 | 0 | 09000064b966e2ec | ||
| FDA-2026-S-0024-0732 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000812 - DOVITA NUTRITION HEALTH LLC - AIDEVI LIVER HEALTH ULTRA - DETOX & REPAIR | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:46:39Z | 0 | 0 | 09000064b966e66d | ||
| FDA-2026-S-0024-0733 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000813 - DOVITA NUTRITION HEALTH LLC - AIDEVI NAD+ SUSTAIN - boosts NAD+ levels | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:46:43Z | 0 | 0 | 09000064b966e66f | ||
| FDA-2026-V-11618-0003 | FDA | Laser Light Show FDA-2026-V-11618 | Variance Approval Letter to Ultimate Rush Floyd, LLC | Other | Approval for Variance (VRA) | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T18:20:27Z | 0 | 0 | 09000064b9664350 | ||
| FDA-2026-P-12444-0001 | FDA | Request that the FDA Establish an Independent Heath Safety Investigation Board with Replay-Analysis Authority for Systemic Review of Regulatory Failures in the Oversight of Foods, Drugs, Biological Products, and Medical Devices FDA-2026-P-12444 | Citizen Petition from John Kelser | Other | Citizen Petition | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:16:47Z | 1 | 0 | 09000064b966d19e | ||
| FDA-2026-P-12444-0005 | FDA | Request that the FDA Establish an Independent Heath Safety Investigation Board with Replay-Analysis Authority for Systemic Review of Regulatory Failures in the Oversight of Foods, Drugs, Biological Products, and Medical Devices FDA-2026-P-12444 | executive_summary_fda_citizen_petition | Supporting & Related Material | Background Material | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T19:17:07Z | 0 | 0 | 09000064b966d1bc | |||
| FDA-2026-P-12444-0008 | FDA | Request that the FDA Establish an Independent Heath Safety Investigation Board with Replay-Analysis Authority for Systemic Review of Regulatory Failures in the Oversight of Foods, Drugs, Biological Products, and Medical Devices FDA-2026-P-12444 | exhibit_3_ntsb_csb_fib_structural_comparison | Supporting & Related Material | Background Material | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T19:17:16Z | 0 | 0 | 09000064b966d1c0 | |||
| 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-H-12247-0001 | FDA | DAB Civil Money Penalty; Winn-Dixie Stores, LLC d/b/a Winn-Dixie 191 FDA-2026-H-12247 | Complaint | Other | Complaint | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T21:52:47Z | 0 | 0 | 09000064b9671b34 | ||
| FDA-2026-H-12249-0001 | FDA | DAB Civil Money Penalty; BJ and George Inc. d/b/a Northside Food Store FDA-2026-H-12249 | Complaint | Other | Complaint | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T22:26:28Z | 0 | 0 | 09000064b9673209 | ||
| FDA-2026-S-0024-0707 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000783 - M D PH NATURAL HEALTH LTD - Made Organics Fluid Balance - Supports healthy fluid balance and gentle water balance regulation in the body | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:44:16Z | 0 | 0 | 09000064b96642a3 | ||
| FDA-2026-S-0024-0721 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000799 - TSI USA LLC - Olive Leaf Extract - provides antioxidant support | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:45:39Z | 0 | 0 | 09000064b966e2f4 | ||
| FDA-2026-S-0024-0735 | FDA | 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 | 2026-000815 - DOVITA NUTRITION HEALTH LLC - AIDEVI MENOPAUSE SUPPORT - Hormone-Balancing | Other | 30 Day Structured Function Claim | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T23:46:56Z | 0 | 0 | 09000064b966e673 | ||
| 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-P-12446-0006 | FDA | Requests that the FDA declare that Diclofenac Sodium Topical Solution, 1.6%, is suitable for submission as an ANDA FDA-2026-P-12446 | Attachment 4 | Supporting & Related Material | Background Material | 2026-10-14T04:00:00Z | 2026 | 10 | 2026-10-15T00:14:10Z | 0 | 0 | 09000064b966d255 | |||
| 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-H-12018-0001 | FDA | DAB Civil Money Penalty; Cleopatra L. Dixon d/b/a Hwy 188 Quick Stop FDA-2026-H-12018 | Complaint | Other | Complaint | 2026-10-14T04:00:00Z | 2026 | 10 | 2026-10-14T04:00:00Z | 2026-10-14T18:12:00Z | 0 | 0 | 09000064b966ae92 | ||
| FDA-2026-P-12446-0005 | FDA | Requests that the FDA declare that Diclofenac Sodium Topical Solution, 1.6%, is suitable for submission as an ANDA FDA-2026-P-12446 | Attachment 3 | Supporting & Related Material | Background Material | 2026-10-14T04:00:00Z | 2026 | 10 | 2026-10-15T00:14:08Z | 0 | 0 | 09000064b966d252 | |||
| FDA-2026-P-12386-0001 | FDA | Requests that the FDA to determine whether the Reference Listed Drug (RLD) URSO 250 and URSO FORTE (Ursodiol) Tablets, 250 mg and 500 mg under New Drug Application (NDA) 020675 held by ABBVIE INC, was voluntarily withdrawn from commercial distribution, or withdrawn from sale for safety or efficacy reasons FDA-2026-P-12386 | Citizen Petition from Strides Pharma, Inc. | Other | Citizen Petition | 2026-10-14T04:00:00Z | 2026 | 10 | 2026-10-14T04:00:00Z | 2026-10-14T15:21:56Z | 1 | 0 | 09000064b9668ef0 |
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