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  • FDA · 225,683 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-P-6737-0009 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 7 - Incorporation of excess gadolinium into human bone from medical contrast agents Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:27:46Z   0 0 09000064b932a303
FDA-2026-P-6737-0012 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 10 - Gadolinium-Based Contrast Agent Accumulation and Toxicity Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:27:55Z   0 0 09000064b932a306
FDA-2026-P-6737-0003 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 1 - Gadolinium-Based Contrast Media Nephrotoxicity in Kidney Impairment Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:27:26Z   0 0 09000064b932a273
FDA-2026-P-6737-0008 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 6 - Literature case analysis of nephrogenic systemic fibrosis induced by gadolinium-based contrast agents Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:27:43Z   0 0 09000064b932a302
FDA-2026-P-6737-0043 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 41 - Long-Term Treatment with Gadopentetic Acid or Gadodiamide Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:44Z   0 0 09000064b932a33d
FDA-2026-P-6737-0040 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 38 - Ultrastructural Evidence of Dermal Gadolinium Deposits Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:34Z   0 0 09000064b932a33a
FDA-2026-P-6737-0045 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 43 - An initial investigation of serum cytokine levels in patients with gadolinium retention Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:50Z   0 0 09000064b932a33f
FDA-2026-P-6737-0030 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 28 - Skin-Related Adverse Reactions in Gadolinium Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:56Z   0 0 09000064b932a326
FDA-2018-N-3240-1005 FDA List of Bulk Drug Substances For Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Notice FDA-2018-N-3240 Request for Extension from Collaborative for Evidence-Based Medicines Other Request for Extension 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:23:23Z   0 0 09000064b9329d1b
FDA-2026-V-4031-0001 FDA Laser Light Show FDA-2026-V-4031 Variance Application from David Wilson Other Application for Variance (VAR) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:28:07Z   0 0 09000064b927c69a
FDA-2004-V-0487-0012 FDA Laser Light Show FDA-2004-V-0487 Variance Approval Letter from FDA CDRH to Clark Planetarium Other Approval for Variance (VRA) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T21:56:44Z   0 0 09000064b932a66a
FDA-2026-P-6789-0002 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. FDA-2026-P-6789 Acknowledgement Letter from FDA DMB to Buchanan Ingersoll & Rooney PC Other Acknowledgement Letter/Receipt 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-16T00:58:01Z   0 0 09000064b932ff3a
FDA-2026-P-6737-0015 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 13 - Prepubertal exposure to gadolinium Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:05Z   0 0 09000064b932a309
FDA-2026-P-6737-0018 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 16 - Immediate adverse reactions to gadolinium-based MR contrast Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:15Z   0 0 09000064b932a30e
FDA-2026-P-6737-0037 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 35 - The Impact of Gadolinium on Quantitative Myelin Metrics Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:23Z   0 0 09000064b932a337
FDA-2026-P-6737-0005 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 3 - Gadolinium retention effect on macrophages Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:27:32Z   0 0 09000064b932a275
FDA-2026-D-2698-0001 FDA Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability FDA-2026-D-2698 Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability Notice Notice of Availability 2026-06-15T04:00:00Z 2026 6     2026-06-15T17:12:16Z 2026-11966 0 0 09000064b932f27d
FDA-2026-N-6404-0001 FDA Amendment and Revocation of Organizational Information Regulations FDA-2026-N-6404 Amendment and Revocation of Organizational Information Regulations Rule Final Rule 2026-06-15T04:00:00Z 2026 6     2026-06-15T17:03:54Z 2026-11998 0 0 09000064b932f2cf
FDA-2026-P-6737-0021 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 19 - Gadolinium-based contrast agent toxicity Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:25Z   0 0 09000064b932a311
FDA-2026-P-6737-0024 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 22 - Gadolinium deposition in bone tissues after contrast-enhanced Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:37Z   0 0 09000064b932a314
FDA-2026-P-6737-0044 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 42 - Altered Functional Mitochondrial Protein Levels in Plasma Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:47Z   0 0 09000064b932a33e
FDA-2026-V-4560-0002 FDA Laser Light Show FDA-2026-V-4560 Acknowledgment Letter from FDA DMB to DJZ Productions Other Acknowledgement Letter/Receipt 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:27:57Z   0 0 09000064b92a571d
FDA-2026-P-4021-0003 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. FDA-2026-P-4021 Final Response Other Letter(s) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:19:21Z   0 0 09000064b9328a95
FDA-2024-V-1078-0005 FDA Laser Light Show FDA-2024-V-1078 Variance Renewal Approval Letter from FDA CDRH to Dog From The Moon LLC Other Approval for Variance (VRA) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:31:34Z   0 0 09000064b9326ee6
FDA-2025-P-7433-0005 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. FDA-2025-P-7433 Interim Response from FDA CDER to University of Illinois, College of Pharmacy Other Response(s) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T23:48:58Z   0 0 09000064b93318f1
FDA-2026-D-2698-0002 FDA Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability FDA-2026-D-2698 Forms FDA 3542a and FDA 3542: Questions and Answers; Guidance for Industry Other Guidance 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z 2026-08-15T03:59:59Z 2026-06-15T17:14:02Z   1 0 09000064b932cc13
FDA-2026-P-6737-0041 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 39 - Delineating toxicity mechanisms associated with MRI contrast Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:37Z   0 0 09000064b932a33b
FDA-2026-P-6737-0023 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 21 - Influence blocking by Gadolinium in Calcium Diffusion Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:33Z   0 0 09000064b932a313
FDA-2026-P-6737-0006 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 4 - Gadolinium accelerates the migration of astrocyte via integrin signaling pathway Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:27:36Z   0 0 09000064b932a300
FDA-2026-P-6737-0007 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 5 - Concentration-Dependent Bidirectional Modification of Evoked Synaptic Transmission by Gadolinium Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:27:40Z   0 0 09000064b932a301
FDA-2026-P-6737-0010 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 8 - Repeated gadolinium Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:27:50Z   0 0 09000064b932a304
FDA-2026-H-6634-0001 FDA DAB Civil Money Penalty; Space Out Smoke Hickory LLC d/b/a Cosmic Smoke FDA-2026-H-6634 Complaint Other Complaint 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T20:18:41Z   0 0 09000064b932ecff
FDA-2026-P-4021-0004 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. FDA-2026-P-4021 Relisting Notice Protamine Sulfate (Protamine Sulfate) IV Solution 50mg per mL Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T22:19:33Z   0 0 09000064b9329751
FDA-2025-P-7112-0003 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 FDA-2025-P-7112 Interim Response Other Letter(s) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:17:54Z   0 0 09000064b932a259
FDA-2020-V-1552-0007 FDA Laser Light Show FDA-2020-V-1552 Variance Amendment Approval Letter from FDA CDRH to LaserAnimation Sollinger GmbH Other Approval for Variance (VRA) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:36:57Z   0 0 09000064b9327f85
FDA-2026-P-6737-0019 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 17 - Effects of Salicylate and Lanthanides on Outer Hair Cell Motility Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:19Z   0 0 09000064b932a30f
FDA-2026-P-6737-0011 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 9 - Gadolinium Mitochondrial Toxicity Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:27:52Z   0 0 09000064b932a305
FDA-2026-P-6737-0017 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 15 - Gadolinium based Contrast Agent Accumulates in the Brain Even in Subjects without Severe Renal Dysfunction Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:11Z   0 0 09000064b932a30d
FDA-2026-P-6737-0028 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 26 - Neurotoxicity from intrathecal gadolinium Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:49Z   0 0 09000064b932a324
FDA-2026-P-6737-0031 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 29 - Acute lung injury following gadolinium contrast Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:00Z   0 0 09000064b932a327
FDA-2026-P-6737-0033 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 31 - Gadolinium-based contrast agent-induced neurotoxicity seeing is believing Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:07Z   0 0 09000064b932a329
FDA-2026-P-6737-0004 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 2 - Gadolinium-based MRI contrast agent effects on calcium signaling Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:27:30Z   0 0 09000064b932a274
FDA-2026-P-6737-0026 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 24 - Effects of Gadolinium-Based MRI Contrast Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:43Z   0 0 09000064b932a322
FDA-2016-V-1231-0006 FDA Variance Request for Class IIIB laser Systems in the MAWL family of products: Models: MAWL-DA, MAWL-DA-B FDA-2016-V-1231 Variance Renewal Request from B.E. Meyers & Company, Inc. Other Request 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T23:16:59Z   0 0 09000064b932fd74
FDA-2026-V-4560-0001 FDA Laser Light Show FDA-2026-V-4560 Variance Application from DJZ Productions Other Application for Variance (VAR) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:27:28Z   0 0 09000064b92a571b
FDA-2026-H-6636-0001 FDA DAB Civil Money Penalty; Express II Corp. d/b/a Express Mart FDA-2026-H-6636 Complaint Other Complaint 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T23:04:37Z   0 0 09000064b932fe34
FDA-2022-V-0385-0005 FDA Laser Light Show FDA-2022-V-0385 Variance Renewal Approval Letter to Brent Parrish Other Approval for Variance (VRA) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:55:51Z   0 0 09000064b932fd52
FDA-2026-P-6789-0001 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. FDA-2026-P-6789 Citizen Petition from Buchanan Ingersoll & Rooney PC Other Citizen Petition 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-16T00:57:45Z   1 0 09000064b932ff38
FDA-2026-P-6737-0014 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 12 - Skin-Related Adverse Reactions in Gadolinium-Based Contrast Agents-Induced Hypersensitivity Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:02Z   0 0 09000064b932a308
FDA-2026-P-6737-0022 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 20 - Human Hair as a Possible Surrogate Marker of Retained Tissue Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:30Z   0 0 09000064b932a312
FDA-2026-P-6737-0013 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 11 - On the interaction of muscle actin with gadolinium Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:27:58Z   0 0 09000064b932a307
FDA-2026-P-6737-0016 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 14 - Contrast-free identification of glioma blood-brain barrier status via generative diffusion AI and non-contrast MRI Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:09Z   0 0 09000064b932a30c
FDA-2026-H-6519-0001 FDA DAB Civil Money Penalty; Victor H Ozuna d/b/a Vico's Drive Thru FDA-2026-H-6519 Complaint Other Complaint 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T19:57:58Z   0 0 09000064b932eb25
FDA-2026-P-6737-0036 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 34 - Immediate Adverse Reactions to Gandolinium-Based MR Contrast Media Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:20Z   0 0 09000064b932a336
FDA-2026-P-6737-0042 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 40 - The involvement of proinflammatory cytokines in nephrogenic systemic fibrosis Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:40Z   0 0 09000064b932a33c
FDA-2026-P-6737-0001 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Citizen Petition from Regina Sutton Other Citizen Petition 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T20:27:13Z   1 0 09000064b9329d15
FDA-2026-P-6737-0002 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Acknowledgement Letter from FDA DMB to Regina Sutton Other Acknowledgement Letter/Receipt 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T20:27:18Z   0 0 09000064b9329d18
FDA-2026-V-4031-0002 FDA Laser Light Show FDA-2026-V-4031 Acknowledgment Letter from FDA DMB to David Wilson Other Acknowledgement Letter/Receipt 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:28:12Z   0 0 09000064b927c6a7
FDA-2026-H-6514-0001 FDA DAB Civil Money Penalty; Jorgui Corporation d/b/a Broadway Wine & Liquors FDA-2026-H-6514 Complaint Other Complaint 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T23:07:07Z   0 0 09000064b9330744
FDA-2026-P-6737-0025 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 23 - Assessment of gadolinium and iodine concentrations in kidney stones Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:40Z   0 0 09000064b932a315
FDA-2026-P-6737-0032 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 30 - Comparison of Human Tissue Gadolinium Retention and Elimination between Gadoteridol and Gadobenate Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:03Z   0 0 09000064b932a328
FDA-2026-P-6737-0027 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 25 - INDUCTION OF EXPRESSION OF PROFIBROTIC CYTOKINES Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:46Z   0 0 09000064b932a323
FDA-2026-P-6737-0020 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 18 - Deposition of Gadolinium in the Central and Peripheral Nervous Systems and Its Effects on Sensory Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:22Z   0 0 09000064b932a310
FDA-2026-P-6737-0034 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 32 - Caught in the act Allergic-like reaction to Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:10Z   0 0 09000064b932a32a
FDA-2026-P-6737-0038 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 36 - Effects of gadolinium Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:26Z   0 0 09000064b932a338
FDA-2026-P-6737-0029 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 27 - Gadolinium during human pregnancy following administration of gadolinium chelate before pregnancy Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:28:52Z   0 0 09000064b932a325
FDA-2026-P-6737-0035 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 33 - Acute respiratory distress syndrome after the use of gadolinium contrast agent. Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:16Z   0 0 09000064b932a32b
FDA-2026-P-6737-0039 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Reference 37 - Gadolinium Contrast Agent Deposition in Children Supporting & Related Material Background Material 2026-06-15T04:00:00Z 2026 6     2026-06-15T20:29:30Z   0 0 09000064b932a339
FDA-2026-V-4031-0003 FDA Laser Light Show FDA-2026-V-4031 Variance Approval Letter to David Wilson Other Approval for Variance (VRA) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:28:17Z   0 0 09000064b932fd41
FDA-2026-V-4560-0003 FDA Laser Light Show FDA-2026-V-4560 Variance Approval Letter from FDA CDRH to DJZ Productions Other Approval for Variance (VRA) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:28:26Z   0 0 09000064b932e7fb
FDA-2024-V-4985-0005 FDA Laser Light Show FDA-2024-V-4985 Variance Approval Letter from FDA CDRH to Projectile Objects LLC Other Approval for Variance (VRA) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T21:53:48Z   0 0 09000064b9329753
FDA-2024-V-1078-0004 FDA Laser Light Show FDA-2024-V-1078 Variance Renewal from Dog From the Moon LLC Other Request 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:31:13Z   0 0 09000064b93240f7
FDA-2026-H-6515-0001 FDA DAB Civil Money Penalty; Deyanira Izaguirre Martinez d/b/a Martinez Mini Mart & Taqueria FDA-2026-H-6515 Complaint Other Complaint 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T23:17:28Z   0 0 09000064b9330741
FDA-2026-H-6513-0001 FDA DAB Civil Money Penalty; Nahkai - Ming Enterprise, LLC d/b/a Smoke House FDA-2026-H-6513 Complaint Other Complaint 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T23:19:07Z   0 0 09000064b933102e
FDA-2025-N-6692-0001 FDA NOOH Proposal to Debar Jeffrey Thies FDA-2025-N-6692 Notice Of Opportunity For Hearing - Thies Other Hearing/Meeting Summary 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T18:28:00Z   0 0 09000064b93284cb
FDA-2026-H-6520-0001 FDA DAB Civil Money Penalty; Broadway Convenience Inc. d/b/a Broadway Convenience FDA-2026-H-6520 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T17:51:15Z   0 0 09000064b9328a8e
FDA-2026-H-6521-0001 FDA DAB Civil Money Penalty; Broadway Gift Inc. d/b/a Broadway Gift Shop FDA-2026-H-6521 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T18:04:32Z   0 0 09000064b93284b7
FDA-2026-H-6511-0001 FDA DAB Civil Money Penalty; BD Supermarket LLC d/b/a BD Supermarket FDA-2026-H-6511 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T20:02:04Z   0 0 09000064b93265f1
FDA-2026-H-6401-0001 FDA DAB Civil Money Penalty; Los Trevi Drive-Thru, LLC d/b/a Los Trevi Drive-Thru 2 FDA-2026-H-6401 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T20:09:45Z   0 0 09000064b9325333
FDA-2026-H-6542-0001 FDA DAB Civil Money Penalty; La Florida Drive Thru LLC d/b/a La Florida Drive Thru FDA-2026-H-6542 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T23:27:56Z   0 0 09000064b9328064
FDA-2026-H-6205-0001 FDA DAB Civil Money Penalty; Cappello Bianco, Inc. d/b/a Il Bistro FDA-2026-H-6205 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T17:44:33Z   0 0 09000064b9327ea5
FDA-2026-H-6508-0001 FDA DAB Civil Money Penalty; Best Choice Liquor Co., LLC d/b/a Best Choice Grocery Liquors FDA-2026-H-6508 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T22:46:15Z   0 0 09000064b9326ea7
FDA-2026-H-6510-0001 FDA DAB Civil Money Penalty; 3 Guys of Tallahassee, LLC d/b/a Skyline Xpress / Marathon FDA-2026-H-6510 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T17:32:21Z   0 0 09000064b9327e99
FDA-2026-H-6545-0001 FDA DAB Civil Money Penalty; Sort Valley LLC d/b/a Mini Max Meat Market 3 FDA-2026-H-6545 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T18:10:18Z   0 0 09000064b93284bd
FDA-2026-H-6518-0001 FDA DAB Civil Money Penalty; Pynk Smoke LLC d/b/a Pynk Smoke FDA-2026-H-6518 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T18:01:29Z   0 0 09000064b93275de
FDA-2026-H-6517-0001 FDA DAB Civil Money Penalty; Bond Drugs, Inc. d/b/a Bond Drugs FDA-2026-H-6517 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T20:04:58Z   0 0 09000064b932551c
FDA-2026-H-6291-0001 FDA DAB Civil Money Penalty; S and H Convenience Inc. d/b/a Mr. Vapor Smoke Shop FDA-2026-H-6291 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T20:22:24Z   0 0 09000064b9328eb0
FDA-2026-H-6546-0001 FDA DAB Civil Money Penalty; Wal-Mart Stores East, LP d/b/a Walmart 1525 FDA-2026-H-6546 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T20:55:18Z   0 0 09000064b9329991
FDA-2026-H-5192-0001 FDA DAB Civil Money Penalty; Pierce Curby LLC d/b/a Holy Smokes FDA-2026-H-5192 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T20:19:35Z   0 0 09000064b9328e0a
FDA-2026-H-6507-0001 FDA DAB Civil Money Penalty; Moonachie Liquor LLC d/b/a Moonachie Liquors FDA-2026-H-6507 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T20:41:04Z   0 0 09000064b932998b
FDA-2026-H-6509-0001 FDA DAB Civil Money Penalty; Fort Lee Foodmart LLC d/b/a Shell / Food Mart / Mangia Thyme FDA-2026-H-6509 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T17:29:57Z   0 0 09000064b9325e2b
FDA-2026-H-6544-0001 FDA DAB Civil Money Penalty; Sinaloa DG LLC d/b/a Sinaloa Drive Thru 2 FDA-2026-H-6544 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T17:47:46Z   0 0 09000064b9327ec1
FDA-2026-R-6399-0001 FDA DAB No Tobacco Sale Order; Northwestern Highway & 12 Mile, Inc. d/b/a Marathon / Food Center FDA-2026-R-6399 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T18:55:26Z   0 0 09000064b932640d
FDA-2026-H-6543-0001 FDA DAB Civil Money Penalty; Lucky King 1 Corp. d/b/a Lucky King 1 FDA-2026-H-6543 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T22:49:20Z   0 0 09000064b9327fd0
FDA-1998-P-0083-0025 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Answer Letter from FDA CDER to American Board of Obstetrics & Gynecology Other Answer 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T00:23:26Z   0 0 09000064b931e98f
FDA-2026-H-6387-0001 FDA DAB Civil Money Penalty; Pines Road Quick Stop LLC d/b/a Get-N-Geaux / Valero FDA-2026-H-6387 Complaint Other Complaint 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T16:12:26Z   0 0 09000064b9322dd5
FDA-2026-H-6393-0001 FDA DAB Civil Money Penalty; B & Gajera LLC d/b/a Quick Mart FDA-2026-H-6393 Complaint Other Complaint 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T17:29:57Z   0 0 09000064b9322c95
FDA-2026-H-6505-0001 FDA DAB Civil Money Penalty; Belleville Fuel Mart Inc. d/b/a Sunoco / FlexxMart FDA-2026-H-6505 Complaint Other Complaint 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T19:29:23Z   0 0 09000064b9324f53
FDA-2026-P-6706-0003 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. FDA-2026-P-6706 Attachment 1 Supporting & Related Material Background Material 2026-06-11T04:00:00Z 2026 6     2026-06-11T21:14:39Z   0 0 09000064b9322c97
FDA-2026-P-6706-0004 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. FDA-2026-P-6706 Attachment 2 Supporting & Related Material Background Material 2026-06-11T04:00:00Z 2026 6     2026-06-11T21:14:44Z   0 0 09000064b9324f61

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    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
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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;