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Regulatory dockets from Regulations.gov — containers for related documents and comments in a rulemaking proceeding.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

8,005 rows where agency_id = "FDA" and docket_type = "Nonrulemaking" sorted by last_modified descending

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docket_type 1

  • Nonrulemaking · 8,005 ✖

agency_id 1

  • FDA · 8,005 ✖
id agency_id title docket_type last_modified ▲ object_id
FDA-2026-P-6789 FDA Requests that the FDA review whether the two primary generic bicalutamide tablet suppliers can assure the safety, efficacy, and quality of bicalutamide tablets for the intended prostate cancer patient population. Nonrulemaking 2026-06-15T20:58:01Z 0b000064b93304e5
FDA-2025-P-7433 FDA Requests that the FDA adopt, or incorporate into existing guidance, a risk-based regulatory framework specific to peptide therapeutics, with particular emphasis on delivery-route acceptability, dose sensitivity, and exposure variability. Nonrulemaking 2026-06-15T19:48:58Z 0b000064b911491e
FDA-2026-H-6513 FDA DAB Civil Money Penalty; Nahkai - Ming Enterprise, LLC d/b/a Smoke House Nonrulemaking 2026-06-15T19:19:07Z 0b000064b931b1db
FDA-2026-N-4492 FDA Drug Repurposing for Unmet Medical Needs; Request for Information Nonrulemaking 2026-06-15T19:18:29Z 0b000064b92a397d
FDA-2026-H-6515 FDA DAB Civil Money Penalty; Deyanira Izaguirre Martinez d/b/a Martinez Mini Mart & Taqueria Nonrulemaking 2026-06-15T19:17:28Z 0b000064b931b56b
FDA-2016-V-1231 FDA Variance Request for Class IIIB laser Systems in the MAWL family of products: Models: MAWL-DA, MAWL-DA-B Nonrulemaking 2026-06-15T19:16:59Z 0b00006481fa6a53
FDA-2026-H-6514 FDA DAB Civil Money Penalty; Jorgui Corporation d/b/a Broadway Wine & Liquors Nonrulemaking 2026-06-15T19:07:07Z 0b000064b931817e
FDA-2026-H-6636 FDA DAB Civil Money Penalty; Express II Corp. d/b/a Express Mart Nonrulemaking 2026-06-15T19:04:36Z 0b000064b931f806
FDA-2022-V-0385 FDA Laser Light Show Nonrulemaking 2026-06-15T18:55:51Z 0b00006484fd84b5
FDA-2026-P-5978 FDA Requests that the FDA declare that Cyproheptadine HCL Tablets, 3 mg and 6 mg, are suitable for submission as an ANDA Nonrulemaking 2026-06-15T18:40:48Z 0b000064b92f3694
FDA-2020-V-1552 FDA Laser Light Show Nonrulemaking 2026-06-15T18:36:57Z 0b000064846e890e
FDA-2024-V-1078 FDA Laser Light Show Nonrulemaking 2026-06-15T18:31:34Z 0b00006486457409
FDA-2026-V-4560 FDA Laser Light Show Nonrulemaking 2026-06-15T18:28:26Z 0b000064b92a71aa
FDA-2026-V-4031 FDA Laser Light Show Nonrulemaking 2026-06-15T18:28:16Z 0b000064b927b7e3
FDA-2018-N-3240 FDA List of Bulk Drug Substances For Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Notice Nonrulemaking 2026-06-15T18:23:23Z 0b00006483640b5b
FDA-2026-P-4021 FDA Requests that the FDA determine whether the Reference Listed Drug (RLD) SPORANOX (ITRACONAZOLE) Oral Solution, 10mg/mL; under New Drug Application (NDA) N020657 held by JANSSEN PHARMACEUTICALS INC, was voluntarily withdrawn from commercial distribution, or withdrawn from sale for safety or efficacy reasons. Nonrulemaking 2026-06-15T18:19:33Z 0b000064b927a186
FDA-2025-P-7112 FDA Requests that FDA determine whether Fluosol® (20% Intravascular Perfluorochemical Emulsion) approved under New Drug Application (NDA) 86-0909, held by Alpha Therapeutic Corporation, has been voluntarily withdrawn from sale for reasons of safety or effectiveness, pursuant to 21 CFR S 314.161 Nonrulemaking 2026-06-15T18:17:54Z 0b000064b90dd2c1
FDA-2004-V-0487 FDA Laser Light Show Nonrulemaking 2026-06-15T17:56:44Z 0b0000648047625c
FDA-2024-V-4985 FDA Laser Light Show Nonrulemaking 2026-06-15T17:53:48Z 0b000064867e8e3e
FDA-2026-H-4330 FDA DAB Civil Money Penalty; PS Dollar Junction Corp d/b/a Jersey Dollar; CLOSED 06/15/2026 Nonrulemaking 2026-06-15T17:23:14Z 0b000064b9292e66
FDA-2026-H-6007 FDA DAB Civil Money Penalty; Wild Bill's Tobacco of Taylor II LLC d/b/a Wild Bill's Tobacco; CLOSED 06/15/2026 Nonrulemaking 2026-06-15T17:21:41Z 0b000064b92f453b
FDA-2026-H-6377 FDA DAB Civil Money Penalty; Lansing Campgrounds, Inc. d/b/a Lansing Cottonwood Campground; CLOSED 06/15/2026 Nonrulemaking 2026-06-15T17:18:06Z 0b000064b930fe10
FDA-2026-P-6737 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. Nonrulemaking 2026-06-15T16:29:50Z 0b000064b9329b6d
FDA-2026-H-6634 FDA DAB Civil Money Penalty; Space Out Smoke Hickory LLC d/b/a Cosmic Smoke Nonrulemaking 2026-06-15T16:18:41Z 0b000064b931f7fe
FDA-2026-H-4690 FDA DAB Civil Money Penalty; Finest Cigar N Vape Corp. d/b/a Finest Cigar N Vape; CLOSED 06/15/2026 Nonrulemaking 2026-06-15T16:01:52Z 0b000064b92b58d5
FDA-2026-H-6519 FDA DAB Civil Money Penalty; Victor H Ozuna d/b/a Vico's Drive Thru Nonrulemaking 2026-06-15T15:57:58Z 0b000064b931b21e
FDA-2026-H-5713 FDA DAB Civil Money Penalty; Naveed Mohammad d/b/a Exhale Smoke Shop; CLOSED 06/15/2026 Nonrulemaking 2026-06-15T15:53:27Z 0b000064b92dc14b
FDA-2026-D-2698 FDA Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability Nonrulemaking 2026-06-15T13:13:19Z 0b000064b921a503
FDA-2026-H-1622 FDA DAB Civil Money Penalty; Prime Time #5 LLC d/b/a Prime Time 5 / Conoco; CLOSED 06/15/2026 Nonrulemaking 2026-06-15T13:08:30Z 0b000064b91a7e88
FDA-2026-H-6542 FDA DAB Civil Money Penalty; La Florida Drive Thru LLC d/b/a La Florida Drive Thru Nonrulemaking 2026-06-12T19:27:56Z 0b000064b931d539
FDA-2026-H-6543 FDA DAB Civil Money Penalty; Lucky King 1 Corp. d/b/a Lucky King 1 Nonrulemaking 2026-06-12T18:49:20Z 0b000064b931cd02
FDA-2026-H-6508 FDA DAB Civil Money Penalty; Best Choice Liquor Co., LLC d/b/a Best Choice Grocery Liquors Nonrulemaking 2026-06-12T18:46:15Z 0b000064b931817a
FDA-2026-H-5448 FDA DAB Civil Money Penalty; Bigfork Liquor Store, LLC, d/b/a Bigfork Liquor Barn; CLOSED 06/12/2026 Nonrulemaking 2026-06-12T18:34:36Z 0b000064b92d4c76
FDA-2026-H-5054 FDA DAB Civil Money Penalty; State Street Mobil Incorporated d/b/a Mobil / State Street Car Care; CLOSED 06/12/2026 Nonrulemaking 2026-06-12T18:25:15Z 0b000064b92c82fc
FDA-2026-H-4016 FDA DAB Civil Money Penalty; Sasakta LLC d/b/a Discount Tobacco Outlet; CLOSED 06/12/2026 Nonrulemaking 2026-06-12T18:00:04Z 0b000064b9273062
FDA-2026-H-4724 FDA DAB Civil Money Penalty; Town Liquors of Algonquin, Inc. d/b/a Town Liquors; CLOSED 06/12/2026 Nonrulemaking 2026-06-12T17:37:54Z 0b000064b92b8957
FDA-2026-H-6546 FDA DAB Civil Money Penalty; Wal-Mart Stores East, LP d/b/a Walmart 1525 Nonrulemaking 2026-06-12T16:55:18Z 0b000064b931e644
FDA-2026-H-6507 FDA DAB Civil Money Penalty; Moonachie Liquor LLC d/b/a Moonachie Liquors Nonrulemaking 2026-06-12T16:41:04Z 0b000064b931b184
FDA-2026-H-4337 FDA DAB Civil Money Penalty; Libra LTD. d/b/a All Star; CLOSED 06/12/2026 Nonrulemaking 2026-06-12T16:22:36Z 0b000064b9293e86
FDA-2026-H-6291 FDA DAB Civil Money Penalty; S and H Convenience Inc. d/b/a Mr. Vapor Smoke Shop Nonrulemaking 2026-06-12T16:22:24Z 0b000064b930c275
FDA-2026-H-5192 FDA DAB Civil Money Penalty; Pierce Curby LLC d/b/a Holy Smokes Nonrulemaking 2026-06-12T16:19:35Z 0b000064b92cfb54
FDA-2026-H-6401 FDA DAB Civil Money Penalty; Los Trevi Drive-Thru, LLC d/b/a Los Trevi Drive-Thru 2 Nonrulemaking 2026-06-12T16:09:45Z 0b000064b9314895
FDA-2026-H-6517 FDA DAB Civil Money Penalty; Bond Drugs, Inc. d/b/a Bond Drugs Nonrulemaking 2026-06-12T16:04:58Z 0b000064b931b56f
FDA-2026-H-6511 FDA DAB Civil Money Penalty; BD Supermarket LLC d/b/a BD Supermarket Nonrulemaking 2026-06-12T16:02:04Z 0b000064b931b1bf
FDA-2026-H-3162 FDA DAB Civil Money Penalty; Midtown Smoke Shop Inc. d/b/a Midtowne Smoke Shop; CLOSED 06/11/2026 Nonrulemaking 2026-06-12T15:31:14Z 0b000064b92388ea
FDA-2026-H-2417 FDA DAB Civil Money Penalty; Best Vape LLC d/b/a S & N Tobacco & Convenience Store; CLOSED 06/11/2026 Nonrulemaking 2026-06-12T15:21:27Z 0b000064b9203c75
FDA-2026-R-6399 FDA DAB No Tobacco Sale Order; Northwestern Highway & 12 Mile, Inc. d/b/a Marathon / Food Center Nonrulemaking 2026-06-12T15:17:50Z 0b000064b931485c
FDA-2026-H-1656 FDA DAB Civil Money Penalty; Vapor Room, LLC d/b/a Vapor Room; CLOSED 6/11//2026 Nonrulemaking 2026-06-12T14:55:59Z 0b000064b91aae8c
FDA-2025-N-6692 FDA NOOH Proposal to Debar Jeffrey Thies Nonrulemaking 2026-06-12T14:28:00Z 0b000064b90abfbb
FDA-2026-H-5687 FDA DAB Civil Money Penalty; Khalida Parveen, d/b/a Sunny Food Mart; CLOSED 06/11/2026 Nonrulemaking 2026-06-12T14:19:04Z 0b000064b92da43f
FDA-2026-H-6545 FDA DAB Civil Money Penalty; Sort Valley LLC d/b/a Mini Max Meat Market 3 Nonrulemaking 2026-06-12T14:10:18Z 0b000064b931e640
FDA-2026-H-6521 FDA DAB Civil Money Penalty; Broadway Gift Inc. d/b/a Broadway Gift Shop Nonrulemaking 2026-06-12T14:04:32Z 0b000064b931b5cd
FDA-2026-H-6518 FDA DAB Civil Money Penalty; Pynk Smoke LLC d/b/a Pynk Smoke Nonrulemaking 2026-06-12T14:01:29Z 0b000064b931b206
FDA-2026-H-6520 FDA DAB Civil Money Penalty; Broadway Convenience Inc. d/b/a Broadway Convenience Nonrulemaking 2026-06-12T13:51:15Z 0b000064b931b573
FDA-2026-H-6544 FDA DAB Civil Money Penalty; Sinaloa DG LLC d/b/a Sinaloa Drive Thru 2 Nonrulemaking 2026-06-12T13:47:46Z 0b000064b931cd06
FDA-2026-H-6205 FDA DAB Civil Money Penalty; Cappello Bianco, Inc. d/b/a Il Bistro Nonrulemaking 2026-06-12T13:44:33Z 0b000064b92ff98d
FDA-2026-H-6510 FDA DAB Civil Money Penalty; 3 Guys of Tallahassee, LLC d/b/a Skyline Xpress / Marathon Nonrulemaking 2026-06-12T13:32:21Z 0b000064b931b1bb
FDA-2026-H-6509 FDA DAB Civil Money Penalty; Fort Lee Foodmart LLC d/b/a Shell / Food Mart / Mangia Thyme Nonrulemaking 2026-06-12T13:29:57Z 0b000064b931b188
FDA-2025-H-2214 FDA DAB Civil Money Penalty; Arch Mini Mart LLC d/b/a Arch Mini Mart; CLOSED 6/12/2026 Nonrulemaking 2026-06-12T13:12:55Z 0b000064b8e5d76d
FDA-2026-H-3945 FDA DAB Civil Money Penalty; Royal Smoke N Vape Inc. d/b/a Royal Smoke & Vape; CLOSED 06/11/2026 Nonrulemaking 2026-06-12T11:39:38Z 0b000064b9267591
FDA-1998-P-0083 FDA Withdrawn From Sale of Tylosterone Tablets Nonrulemaking 2026-06-11T21:06:51Z 0b00006480584ac8
FDA-2026-H-6506 FDA DAB Civil Money Penalty; Hazal Tobacco 2 LLC d/b/a Tobacco Hut Nonrulemaking 2026-06-11T20:03:19Z 0b000064b931b180
FDA-2026-N-2366 FDA Commissioner’s National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments Nonrulemaking 2026-06-11T19:55:59Z 0b000064b91fce17
FDA-2026-H-0730 FDA DAB Civil Money Penalty; MCD Holdings, LLC, d/b/a Noah Smoke Shop; CLOSED 06/11/2026 Nonrulemaking 2026-06-11T19:12:58Z 0b000064b9181eb5
FDA-2026-H-2377 FDA DAB Civil Money Penalty; Gravitate Smoke Shop 4, LLC, d/b/a Gravitate Smoke Shop; CLOSED 6/11/2026 Nonrulemaking 2026-06-11T19:08:09Z 0b000064b91faf57
FDA-2026-H-5746 FDA DAB Civil Money Penalty; Kwang I. Han d/b/a Han's Deli & Grocery; CLOSED 06/11/2026 Nonrulemaking 2026-06-11T19:05:36Z 0b000064b92de31d
FDA-2026-N-1832 FDA Generally Recognized as Safe (GRAS) Notices Filed in 2026 Nonrulemaking 2026-06-11T19:00:21Z 0b000064b91be3d4
FDA-2026-H-6254 FDA DAB Civil Money Penalty; Yellow Store Inc. d/b/a Z Mart Convenience Stores; CLOSED 06/11/2026 Nonrulemaking 2026-06-11T17:50:58Z 0b000064b9307e9b
FDA-2026-V-6106 FDA Laser Light Show Nonrulemaking 2026-06-11T17:47:42Z 0b000064b92fb1f2
FDA-2026-V-5715 FDA Laser Light Show Nonrulemaking 2026-06-11T17:45:49Z 0b000064b92db899
FDA-2026-N-1321 FDA ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing Nonrulemaking 2026-06-11T17:15:21Z 0b000064b9195557
FDA-2026-P-6706 FDA Requests that the FDA declare that an ANDA may be submitted for, Modafinil Tablets, USP 50 mg and 150 mg, 2 strengths that differ from the currently approved RLD, PROVIGIL (Modafinil) tablets from NUVO PHARMACEUTICALS (IRELAND) DAC, which FDA approved in 100 mg and 200 mg strengths on Dec 24th, 1998 under NDA #020717. Nonrulemaking 2026-06-11T17:14:50Z 0b000064b9324f2e
FDA-2023-F-5684 FDA Filing of Food Additive Petition from Environmental Defense Fund, et al.; Request to Amend the Food Additive Regulations to Remove the Solvents Benzene, Ethylene Dichloride, Methylene Chloride, and Trichloroethylene Nonrulemaking 2026-06-11T16:57:58Z 0b0000648635aba4
FDA-2022-D-0795 FDA Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Nonrulemaking 2026-06-11T16:57:32Z 0b00006485071ade
FDA-2026-H-3802 FDA DAB Civil Money Penalty; HJ Khalsa LLC d/b/a Franklin Package Store; CLOSED 06/11/2026 Nonrulemaking 2026-06-11T16:47:15Z 0b000064b925f16f
FDA-2021-D-0368 FDA Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry; Availability Nonrulemaking 2026-06-11T16:45:56Z 0b00006484aa1835
FDA-2020-D-2307 FDA Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability Nonrulemaking 2026-06-11T16:25:00Z 0b000064849a59b3
FDA-2026-H-3871 FDA DAB Civil Money Penalty; Tripura, LLC d/b/a Roadway; CLOSED 06/11/2026 Nonrulemaking 2026-06-11T16:14:24Z 0b000064b9262d5c
FDA-2017-D-6569 FDA Clinical and Patient Decision Support Software Nonrulemaking 2026-06-11T16:03:05Z 0b00006482c92bd2
FDA-2026-H-6390 FDA DAB Civil Money Penalty; Farm Fresh of Carterville, Inc. d/b/a Farm Fresh Nonrulemaking 2026-06-11T16:02:30Z 0b000064b9312b04
FDA-2026-P-6705 FDA Request that the FDA declare that the drug product, generic ivermectin (1.87%) oral liquid is suitable for submission in an Abbreviated New Animal Drug Application (ANADA) Nonrulemaking 2026-06-11T16:01:43Z 0b000064b9324357
FDA-2016-D-1307 FDA Questions and Answers Regarding Drug and Device Manufacturer Communications with Payors; Draft Guidance for Industry; Availability Nonrulemaking 2026-06-11T16:01:04Z 0b00006481fe0873
FDA-2016-D-1280 FDA International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of FDA Regional Implementation Specifications for ICH E2B(R3) Reporting to the FDA Adverse Event Reporting System (FAERS) Nonrulemaking 2026-06-11T16:00:41Z 0b00006481fd2f23
FDA-2026-H-3937 FDA DAB Civil Money Penalty; SSS Texn Corporation d/b/a LaMa / Mobil; CLOSED 06/11/2026 Nonrulemaking 2026-06-11T15:58:47Z 0b000064b9267521
FDA-2026-H-6371 FDA DAB Civil Money Penalty; Smoke & Hookah Zone LLC d/b/a Smoke & Hookah Zone Nonrulemaking 2026-06-11T15:56:54Z 0b000064b930e0a1
FDA-2014-N-1130 FDA Brain-Computer Interface Devices for Patients with Paralysis and Amputation; Public Workshop; Request for Comments Nonrulemaking 2026-06-11T15:52:33Z 0b0000648180235a
FDA-2014-N-1039 FDA General Wellness Products Draft Guidance for Industry and Food and Drug Nonrulemaking 2026-06-11T15:52:00Z 0b000064817cf8de
FDA-2026-H-3876 FDA DAB Civil Money Penalty; Allen Park Mini Mart Inc. d/b/a Smoketopia; CLOSED 06/11/2026 Nonrulemaking 2026-06-11T15:39:20Z 0b000064b92631a2
FDA-2026-H-6505 FDA DAB Civil Money Penalty; Belleville Fuel Mart Inc. d/b/a Sunoco / FlexxMart Nonrulemaking 2026-06-11T15:29:23Z 0b000064b931b168
FDA-2026-H-6397 FDA DAB Civil Money Penalty; Al-Awwal Inc. d/b/a Tony’s Marathon / JK Food Mart Nonrulemaking 2026-06-11T15:27:03Z 0b000064b9314836
FDA-2026-H-3939 FDA DAB Civil Money Penalty; Mecho Supermarket LLC d/b/a Mecho Super Market; CLOSED 06/11/2026 Nonrulemaking 2026-06-11T15:21:27Z 0b000064b9267547
FDA-2025-R-4434 FDA DAB No Tobacco Sale Order; FHM Fuel, Inc. d/b/a Marathon; CLOSED 06/11/2026 Nonrulemaking 2026-06-11T15:17:05Z 0b000064b8fe3c60
FDA-2026-H-6391 FDA DAB Civil Money Penalty; Bright Stars Enterprises Inc. d/b/a Conway Food N Fuel / Phillips 66 Nonrulemaking 2026-06-11T15:05:13Z 0b000064b9312bdd
FDA-2026-H-3878 FDA DAB Civil Money Penalty; O A Supreme, LLC d/b/a Supreme Mart; CLOSED 06/11/2026 Nonrulemaking 2026-06-11T15:00:16Z 0b000064b9262dd7
FDA-2011-N-0656 FDA Animal Drug User Fee Act; Public Meeting Nonrulemaking 2026-06-11T14:56:00Z 0b00006480f13b96
FDA-2026-H-3996 FDA DAB Civil Money Penalty; Zian Enterprise Inc., d/b/a Smoke Shop Convenience & Grocery; CLOSED 06/11/2026 Nonrulemaking 2026-06-11T14:50:32Z 0b000064b927200d
FDA-2011-D-0611 FDA Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 Nonrulemaking 2026-06-11T14:47:57Z 0b00006480eea17a
FDA-2026-H-3940 FDA DAB Civil Money Penalty; Martin Diaz d/b/a 123 Drive Thru; CLOSED 06/11/2026 Nonrulemaking 2026-06-11T14:47:07Z 0b000064b926754b
FDA-2007-D-0369 FDA Industry Describing Product-Specific Bioequivalence Recommendations Nonrulemaking 2026-06-11T14:29:42Z 0b0000648042bb86
FDA-1998-D-0019 FDA Investigating out of Specification(OOS)Test Results fr Pharm Nonrulemaking 2026-06-11T14:29:02Z 0b00006480563cc6

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CREATE TABLE dockets (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    title TEXT,
    docket_type TEXT,
    last_modified TEXT,
    object_id TEXT
);
CREATE INDEX idx_dockets_agency ON dockets(agency_id);
CREATE INDEX idx_dockets_type ON dockets(docket_type);
Powered by Datasette · Queries took 476.749ms · Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API