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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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)

35,428 rows where posted_year = 2026 sorted by posted_date descending

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agency_id >30

  • EPA 16,813
  • FDA 11,412
  • FAA 2,270
  • FWS 774
  • DOT 526
  • SEC 426
  • FERC 355
  • FMCSA 304
  • ITA 260
  • FRA 212
  • APHIS 147
  • USCG 133
  • PHMSA 114
  • USDA 112
  • NRC 99
  • MARAD 97
  • NOAA 85
  • FCC 79
  • VA 78
  • NCUA 76
  • ED 58
  • CMS 53
  • DEA 53
  • NHTSA 52
  • OFAC 45
  • NARA 44
  • DOD 39
  • HUD 37
  • OSHA 36
  • DOE 30
  • …

document_type 5

  • Supporting & Related Material 20,242
  • Other 10,261
  • Notice 3,535
  • Rule 767
  • Proposed Rule 623

posted_year 1

  • 2026 · 35,428 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
APHIS-2024-0040-0008 APHIS Availability of an Environmental Assessment for release of Aceria salsolae for biological control of Russian thistle APHIS-2024-0040 Decision and Finding of No Significant Impact for the Field Release of Aceria salsolae (Acari: Eriophyidae), a Mite for Biological Control of Russian Thistle (Salsola tragus), in the Contiguous United States August 2025 Supporting & Related Material Finding of no Significant Impact 2026-09-15T04:00:00Z 2026 9     2026-09-16T00:13:17Z   0 0 09000064b94ba852
APHIS-2024-0040-0007 APHIS Availability of an Environmental Assessment for release of Aceria salsolae for biological control of Russian thistle APHIS-2024-0040 Field Release of Aceria salsolae (Acari: Eriophyidae), a Mite for Biological Control of Russian Thistle (Salsola tragus), in the Contiguous United States Environmental Assessment August 2025 Supporting & Related Material Environmental Assessment 2026-09-15T04:00:00Z 2026 9     2026-09-16T00:13:13Z   0 0 09000064b94ba853
APHIS-2024-0040-0006 APHIS Availability of an Environmental Assessment for release of Aceria salsolae for biological control of Russian thistle APHIS-2024-0040 Environmental Assessments; Availability, etc.: Field Release of Aceria salsolae (Acari: Eriophyidae), a Mite for Biological Control of Russian Thistle (Salsola tragus), in the Contiguous United States, Finding of No Significant Impact Notice Availability of Document 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:01:33Z 2026-18858 0 0 09000064b955aedf
EPA-R09-OAR-2021-0864-0006 EPA Part 71 Permit Application for Cache Creek Casino Resort EPA-R09-OAR-2021-0864 Draft Permit for Cache Creek Casino Resort Other   2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z 2026-10-16T03:59:59Z 2026-09-16T02:56:08Z   1 0 09000064b956324a
EPA-R09-OAR-2021-0864-0002 EPA Part 71 Permit Application for Cache Creek Casino Resort EPA-R09-OAR-2021-0864 Section 1 - Application Supporting & Related Material   2026-09-15T04:00:00Z 2026 9     2026-09-16T02:48:45Z   0 0 09000064b956326f
EPA-R09-OAR-2021-0864-0003 EPA Part 71 Permit Application for Cache Creek Casino Resort EPA-R09-OAR-2021-0864 Section 2 - Draft Permit and Related Documents Supporting & Related Material   2026-09-15T04:00:00Z 2026 9     2026-09-16T02:48:52Z   0 0 09000064b95632a4
EPA-HQ-OLEM-2022-0903-0667 EPA Alabama Coal Combustion Residuals Permit Program EPA-HQ-OLEM-2022-0903 Transcript from the Alabama CCR permit program proposed approval public hearing. September 3, 2026 Supporting & Related Material Transcript 2026-09-15T04:00:00Z 2026 9     2026-09-15T21:56:20Z   0 0 09000064b9551fb6
EPA-HQ-OPP-2022-0308-0003 EPA Exemption from the Requirement of a Tolerance (Bacillus amyloliquefaciens strain AT-332) EPA-HQ-OPP-2022-0308 Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Bacillus amyloliquefaciens strain AT-332 Rule   2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z 2026-11-17T04:59:59Z 2026-09-15T17:12:30Z 2026-18830 1 0 09000064b955b091
EPA-R09-OAR-2021-0864-0004 EPA Part 71 Permit Application for Cache Creek Casino Resort EPA-R09-OAR-2021-0864 Section 3 - Supporting Documents Supporting & Related Material   2026-09-15T04:00:00Z 2026 9     2026-09-16T02:49:03Z   0 0 09000064b95632a6
EPA-R09-OAR-2021-0864-0005 EPA Part 71 Permit Application for Cache Creek Casino Resort EPA-R09-OAR-2021-0864 Draft Permit Docket Index - Cache Creek Other   2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-16T02:53:43Z   0 0 09000064b95632e5
FDA-2026-P-10739-0001 FDA Request that the FDA declare that the drug product, Mirtazapine Tablet 5 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-10739 Suitability Petition from Senores Pharmaceuticals, Inc. Other Petition(s) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T15:27:02Z   1 0 09000064b9551619
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-P-10693-0064 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 51 - Product Monograph for VEMLIDY Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:12Z   0 0 09000064b95243f1
FDA-2026-P-10693-0067 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 54 - Jones - The CryoEM Method MicroED as a Powerful Tool for Small Molecule Structure Determination Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:23Z   0 0 09000064b95243f4
FDA-2026-P-10693-0079 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 66 - FDA Petition Response to Katherine M Sanzo Lawrence S Ganslaw - Morgan Lewis Bockius et al Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:13Z   0 0 09000064b9524432
FDA-2026-P-10693-0084 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 71 - Orange Book Product Details for NDA 018877 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:37Z   0 0 09000064b9524487
FDA-2026-P-10693-0090 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 77 - LEVOXYL Prescribing Information Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:59Z   0 0 09000064b952448d
FDA-2026-P-10693-0008 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Appendix 1 Exhibit 4 - Lengauer 2020 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:45:33Z   0 0 09000064b95244bc
FDA-2026-P-10693-0016 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 03 - FDA - Approval Letter for VEMLIDY Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:18Z   0 0 09000064b951d4ff
FDA-2026-P-10693-0018 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 05 - Exclusivity Summary for VEMLIDY - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:26Z   0 0 09000064b9522501
FDA-2026-P-10693-0019 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 06 - Wang - On the Single-Crystal Structure of Tenofovir Alafenamide Mono-Fumarate Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:31Z   0 0 09000064b9522502
FDA-2026-P-10693-0039 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 26 - Drugs at FDA - DESCOVY and VEMLIDY Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:01Z   0 0 09000064b9524324
FDA-2026-P-10693-0058 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 45 - Zumdahl - Chemistry Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:35Z   0 0 09000064b95243b9
FDA-2026-H-10568-0001 FDA DAB Civil Money Penalty; Akmal Inc. d/b/a Cloud 9 Smoke Shop FDA-2026-H-10568 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T20:52:57Z   0 0 09000064b9561586
FDA-2026-H-10576-0001 FDA DAB Civil Money Penalty; Knudson Management Inc., d/b/a Cenex / Wild Rice Depot FDA-2026-H-10576 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:55:30Z   0 0 09000064b956161f
FDA-2026-H-10578-0001 FDA DAB Civil Money Penalty; King Westchester Deli Grocery Inc., d/b/a King Westchester Deli Grocery FDA-2026-H-10578 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T18:54:09Z   0 0 09000064b955acc2
FDA-2026-P-10785-0003 FDA Requests that the FDA declare that the drug products Famotidine Capsules, 20 mg and 40 mg, are suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-10785 Attachment 1 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-16T00:12:04Z   0 0 09000064b9560709
FDA-2026-P-10779-0001 FDA Requests that the FDA determine and declare that Propylthiouracil Tablets, 100 mg and 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-10779 Suitability Petition from Quagen Pharmaceuticals LLC Other Petition(s) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T21:31:01Z   1 0 09000064b954cdad
FDA-2026-H-10585-0001 FDA DAB Civil Money Penalty; Save Liquor LLC, d/b/a SAVE / Southside Express Convenience Store FDA-2026-H-10585 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T23:31:29Z   0 0 09000064b9563241
FDA-2026-H-10572-0001 FDA DAB Civil Money Penalty; Kernaghan's Service, Inc. d/b/a Kernaghans Pik & Pump / Conoco FDA-2026-H-10572 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-16T00:19:43Z   0 0 09000064b95616fe
FDA-2026-P-10739-0004 FDA Request that the FDA declare that the drug product, Mirtazapine Tablet 5 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-10739 Attachment 2-RLD Package Insert Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T15:27:15Z   0 0 09000064b954f70c
FDA-2026-P-10693-0023 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 10 - July 29 Notice Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:47Z   0 0 09000064b95242d8
FDA-2026-P-10693-0031 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 18 - FDA - Petition Response to Gary Veron on Behalf of Mutual Pharm Co Inc Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:29Z   0 0 09000064b952431c
FDA-2026-P-10693-0032 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 19 - 67 Fed Reg 66593 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:33Z   0 0 09000064b952431d
FDA-2026-P-10693-0033 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 20 - DESCOVY Container Label Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:37Z   0 0 09000064b952431e
FDA-2026-P-10693-0036 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 23 - TEKTURNA Prescribing Information Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:49Z   0 0 09000064b9524321
FDA-2026-P-10693-0038 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 25 - Orange Book 46th ed - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:58Z   0 0 09000064b9524323
FDA-2026-P-10693-0042 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 29 - Draft Guidance - Ematricitabine TAF Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:15Z   0 0 09000064b9524377
FDA-2026-P-10693-0056 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 43 - USAN Council - Statement on Aliskiren Fumarate Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:27Z   0 0 09000064b95243b7
FDA-2026-P-10693-0072 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 59 - Meet Yale Maestro of MicroED Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:47Z   0 0 09000064b952442b
FDA-2026-P-10693-0075 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 62 - Final Brief for Federal Defendants-Appellees Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:59Z   0 0 09000064b952442e
FDA-2026-P-10693-0082 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 69 - Amarin Pharma Inc v Apotex Inc Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:24Z   0 0 09000064b9524485
FDA-2026-P-10693-0083 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 70 - Orange Book Product Details for NDA 018832 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:28Z   0 0 09000064b9524486
FDA-2026-P-10693-0005 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Appendix 1 Exhibit 2 part 1- XtalPi Report Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:45:21Z   0 0 09000064b95244b9
FDA-2021-V-0331-0005 FDA Laser Light Show FDA-2021-V-0331 Variance Approval Letter from FDA CDRH to OSA International, INC Other Approval for Variance (VRA) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:57:18Z   0 0 09000064b955bc37
FDA-2026-P-10693-0002 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Acknowledgement Letter from FDA DMB to Gilead Sciences, Inc. Other Acknowledgement Letter/Receipt 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:44:45Z   0 0 09000064b9523abe
FDA-2026-H-10573-0001 FDA DAB Civil Money Penalty; The Magic Mushroom, LLC d/b/a The Magic Mushroom FDA-2026-H-10573 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:41:59Z   0 0 09000064b955ede1
FDA-2016-N-3120-0585 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Notice of Participation Other Public Participation 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:09:35Z   0 0 09000064b95549cd
FDA-2026-H-10581-0001 FDA DAB Civil Money Penalty; Smokers Choice 1 LLC, d/b/a Smoker’s Choice FDA-2026-H-10581 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:24:09Z   0 0 09000064b955acc8
FDA-2026-H-10575-0001 FDA DAB Civil Money Penalty; Gold Mini Mart Corp. d/b/a Gold Mini Mart FDA-2026-H-10575 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T20:41:55Z   0 0 09000064b9561078
FDA-2026-P-10779-0004 FDA Requests that the FDA determine and declare that Propylthiouracil Tablets, 100 mg and 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-10779 Attachment 1 - Current Orange Book Details for RLD and Others Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T21:33:26Z   0 0 09000064b9562c09
FDA-2026-P-9802-0008 FDA Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application (ANDA) for Dabrafenib Capsules, 100 mg strength FDA-2026-P-9802 Amendment to Suitability Petition from Spencer Fane LLP Other Amendment 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T21:45:29Z   1 0 09000064b9561667
FDA-2026-P-10785-0006 FDA Requests that the FDA declare that the drug products Famotidine Capsules, 20 mg and 40 mg, are suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-10785 Attachment 4 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-16T00:12:12Z   0 0 09000064b9560858
FDA-2023-V-0784-0004 FDA Laser Light Show FDA-2023-V-0784 Variance Renewal from Dawnpatrol LLC Other Application for Variance (VAR) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-16T00:26:36Z   0 0 09000064b9512871
FDA-2026-P-10739-0002 FDA Request that the FDA declare that the drug product, Mirtazapine Tablet 5 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-10739 Acknowledgment Letter from FDA DMB to Senores Pharmaceuticals, Inc. Other Acknowledgement Letter/Receipt 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T15:27:07Z   0 0 09000064b955161c
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-P-10693-0015 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 02 - DESCOVY Prescribing Information Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:13Z   0 0 09000064b951d4fe
FDA-2026-P-10693-0017 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 04 - VEMLIDY Prescribing Information Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:22Z   0 0 09000064b9522500
FDA-2026-P-10693-0020 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 07 - Lengauer - Co-crystals Salts or Mixtures of Both Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:35Z   0 0 09000064b9522503
FDA-2026-P-10693-0022 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 09 - July 16 Notice Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:43Z   0 0 09000064b95242d7
FDA-2026-P-10693-0028 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 15 - FDA Petition Response to David Platt MD - Novartis Pharmaceuticals Corp Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:07Z   0 0 09000064b95242dd
FDA-2026-P-10693-0043 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 30 - Draft Guidance - Tenofovir Alafenamide Fumarate Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:19Z   0 0 09000064b9524378
FDA-2026-P-10693-0046 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 33 - CDER Product Quality Review Quality Assessment for NDA 209299 TAVALISSE - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:31Z   0 0 09000064b952437b
FDA-2026-P-10693-0047 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 34 - CDER Pharmacology Review for NDA 207561 GENVOYA - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:35Z   0 0 09000064b952437c
FDA-2026-P-10693-0052 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 39 - USAN Council - Statement of a Nonproprietary Name Adopted - TAM Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:11Z   0 0 09000064b95243b3
FDA-2026-P-10693-0062 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 49 - CONFIDENTIAL DESCOVY NDA - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:55Z   0 0 09000064b95243ef
FDA-2026-P-10693-0069 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 56 - Kuballa Liquid Nuclear Magnetic Resonance Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:33Z   0 0 09000064b95243f6
FDA-2026-P-10693-0070 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 57 - Guidance - ANDAs Pharmaceutical Solid Polymorphism Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:38Z   0 0 09000064b95243f7
FDA-2026-P-10693-0074 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 61 - Mooney - Nitrogen Magnetic Resonance Spectroscopy Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:55Z   0 0 09000064b952442d
FDA-2026-P-10693-0089 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 76 - NOVOTHYROX Prescribing Information Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:55Z   0 0 09000064b952448c
FDA-2026-P-10693-0004 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Appendix 1 Exhibit 1 - Mercado CV Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:45:15Z   0 0 09000064b95244b8
FDA-2026-P-10693-0013 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Appendix 1 Exhibit 9 - Wang 2020 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:45:53Z   0 0 09000064b9525939
FDA-2026-V-10397-0003 FDA Laser Light Show FDA-2026-V-10397 Variance Approval Letter from FDA CDRH to TMRW Sports Group, dba "TGL", "WTGL" Other Approval for Variance (VRA) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:28:58Z   0 0 09000064b955bc35
FDA-2026-P-10693-0001 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Citizen Petition from Gilead Sciences, Inc. Other Citizen Petition 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:44:40Z   1 0 09000064b9523a58
FDA-2026-P-10785-0004 FDA Requests that the FDA declare that the drug products Famotidine Capsules, 20 mg and 40 mg, are suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-10785 Attachment 2 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-16T00:12:06Z   0 0 09000064b956070a
FDA-2026-P-10779-0003 FDA Requests that the FDA determine and declare that Propylthiouracil Tablets, 100 mg and 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-10779 Table of Contents Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T21:33:23Z   0 0 09000064b955efca
FDA-2026-P-10779-0005 FDA Requests that the FDA determine and declare that Propylthiouracil Tablets, 100 mg and 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-10779 Attachment 2 - RLD Labeling Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T21:33:29Z   0 0 09000064b9562c0a
FDA-2016-N-3120-0584 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Notice of Entry of Appearance Other Appearance Request 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:09:30Z   0 0 09000064b95549cb
FDA-2025-P-1807-0368 FDA Petition for Reclassification of Covid-19 mRNA And Adenoviral Vector Products as Gene Therapy Products and for Regulatory Action Regarding the Statutory Violations and International Legal Contraventions Inherent in the Covid-19 Countermeasures Program FDA-2025-P-1807 Response Letter Other Response(s) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:11:17Z   0 0 09000064b955ee1b
FDA-2024-V-2018-0005 FDA Laser Light Show FDA-2024-V-2018 Variance Renewal Approval Letter from FDA CDRH to Dorsal Entertainment LLC Other Approval for Variance (VRA) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-16T00:15:06Z   0 0 09000064b955bc27
FDA-2026-V-10397-0002 FDA Laser Light Show FDA-2026-V-10397 Acknowledgment Letter from FDA DMB to TMRW Sports Group, dba "TGL", "WTGL" Other Acknowledgement Letter/Receipt 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:28:51Z   0 0 09000064b94d0682
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 2026-09-15T17:15:44Z 2026-18805 1 0 09000064b955afbc
FDA-2026-N-1832-0052 FDA Generally Recognized as Safe (GRAS) Notices Filed in 2026 FDA-2026-N-1832 GRAS Notice (GRN) 1291 - Amendments - Wattle (Acacia longifolia) seeds Notice General Notice 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T15:13:34Z   0 0 09000064b9554837
FDA-2026-H-10570-0001 FDA DAB Civil Money Penalty; Hannibal Sandy’s, Inc. d/b/a BP / To Go FDA-2026-H-10570 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T18:16:47Z   0 0 09000064b955edfa
FDA-2026-P-10693-0025 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 12 - Draft Guidance - Determining Whether to Submit an ANDA Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:55Z   0 0 09000064b95242da
FDA-2026-P-10693-0026 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 13 - Draft Guidance - Applications Covered by Section 505 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:59Z   0 0 09000064b95242db
FDA-2026-P-10693-0029 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 16 - Guidance - Regulatory Classification of Pharmaceutical Co-Crystals Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:20Z   0 0 09000064b95242de
FDA-2026-P-10693-0037 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 24 - TEKTURNA Prescribing Information Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:53Z   0 0 09000064b9524322
FDA-2026-P-10693-0045 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 32 - CDER Chemistry Review for NDA 208215 DESCOVY - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:27Z   0 0 09000064b952437a
FDA-2026-P-10693-0054 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 41 - WHO Guidance - Use of INNs Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:19Z   0 0 09000064b95243b5
FDA-2026-P-10693-0057 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 44 - Novartis Pharmaceuticals Corporation v Becerra Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:31Z   0 0 09000064b95243b8
FDA-2026-P-10693-0059 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 46 - Cruz-Cabeza - The Role of Solvation in Proton Transfer Reactions Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:39Z   0 0 09000064b95243ba
FDA-2026-P-10693-0066 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 53 - Newman From Powders to Single Crystals Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:19Z   0 0 09000064b95243f3
FDA-2026-P-10693-0078 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 65 - FDA Petition Response to Scott H Korn MD FACP - Merck Sharpe Dohme Corp Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:09Z   0 0 09000064b9524431
FDA-2026-P-10693-0081 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 68 - Draft Guidance - Safety Labeling Changes Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:20Z   0 0 09000064b9524484
FDA-2026-P-10693-0091 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 78 - Guidance - Evaluation of Therapeutic Equivalence Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:52:03Z   0 0 09000064b95244b6
FDA-2026-P-10693-0012 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Appendix 1 Exhibit 8 - Clabbers 2022 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:45:49Z   0 0 09000064b9525938
FDA-2026-H-10577-0001 FDA DAB Civil Money Penalty; Lake Life Petro LLC, d/b/a Jacksonville Marathon FDA-2026-H-10577 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T18:51:22Z   0 0 09000064b9557ee1
FDA-2026-H-10583-0001 FDA DAB Civil Money Penalty; Pic N Tote Two LLC, d/b/a Pic N Tote / VP Racing Fuels FDA-2026-H-10583 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:59:11Z   0 0 09000064b9561655
FDA-2024-P-1871-0015 FDA Requests the Commissioner to ensure that applications submitted under 505(j) and 505(b)(2) that rely on Lutathera include data necessary to show that a proposed product is pharmaceutically equivalent, bioequivalent, and can be expected to have the same clinical effect and safety profile as Lutathera when administered to patients under the conditions specified in the labeling FDA-2024-P-1871 Reconsideration Response Other Letter(s) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:17:41Z   0 0 09000064b9554926

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
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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,
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    withdrawn INTEGER,
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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;
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