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Denial of Hearing; Final Debarment Order", "Notice", "Statutory Debarment", "2024-12-05T05:00:00Z", 2024, 12, "2024-12-05T05:00:00Z", null, "2024-12-05T13:56:24Z", "2024-28452", 1, 0, "0900006486849adc"], ["FDA-2022-D-2628-0035", "FDA", "FDA-2022-D-2628", "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2024-12-04T05:00:00Z", 2024, 12, null, null, "2024-12-04T14:43:53Z", "2024-28361", 0, 0, "0900006486848770"], ["FDA-2024-D-1334-0001", "FDA", "FDA-2024-D-1334", "Notifying the Food and Drug Administration of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request", "Notice", "Notice of Availability", "2024-12-04T05:00:00Z", 2024, 12, null, null, "2024-12-04T14:30:12Z", "2024-28230", 0, 0, "09000064868487b9"], ["FDA-1993-D-0285-0012", "FDA", "FDA-1993-D-0285", "Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis; 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KEBILIDI (eladocagene exuparvovectneq)", "Notice", "Announcement", "2024-12-02T05:00:00Z", 2024, 12, "2024-12-02T05:00:00Z", null, "2024-12-02T15:11:50Z", "2024-28206", 0, 0, "0900006486843d8e"], ["FDA-2024-N-4085-0026", "FDA", "FDA-2024-N-4085", "Advancing Smoking Cessation: Food and Drug Administration and National\nInstitutes of Health Priorities; Public Meeting; Request for Comments; Reopening of Public Comment Period", "Notice", "Extension of Comment Period", "2024-12-02T05:00:00Z", 2024, 12, null, null, "2024-12-02T13:43:03Z", "2024-28205", 0, 0, "0900006486843e07"], ["FDA-2024-N-5253-0001", "FDA", "FDA-2024-N-5253", "Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public\nDocket; Request for Comments\u2014 Biologics License Application 761393 for Condoliase Injection", "Notice", "Request for Comments", "2024-12-02T05:00:00Z", 2024, 12, "2024-12-02T05:00:00Z", "2025-01-10T04:59:59Z", "2025-01-10T02:00:46Z", "2024-28210", 0, 0, "09000064868434ce"], ["FDA-2024-N-4731-0001", "FDA", "FDA-2024-N-4731", "Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices", "Notice", "60 Day Proposed Information Collection", "2024-11-29T05:00:00Z", 2024, 11, "2024-11-29T05:00:00Z", "2025-01-29T04:59:59Z", "2024-11-29T15:29:20Z", "2024-28044", 0, 0, "090000648683e886"], ["FDA-2024-N-4754-0001", "FDA", "FDA-2024-N-4754", "Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators", "Notice", "60 Day Proposed Information Collection", "2024-11-29T05:00:00Z", 2024, 11, "2024-11-29T05:00:00Z", "2025-01-29T04:59:59Z", "2025-01-29T02:00:56Z", "2024-28034", 0, 0, "090000648683f0a1"], ["FDA-2022-D-0084-0021", "FDA", "FDA-2022-D-0084", "Use of Circulating Tumor Deoxyribonucleic Acid for Curative- Intent Solid Tumor Drug Development; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2024-11-29T05:00:00Z", 2024, 11, "2024-11-29T05:00:00Z", null, "2024-11-29T15:07:39Z", "2024-28033", 0, 0, "090000648683f00a"], ["FDA-2024-N-4687-0001", "FDA", "FDA-2024-N-4687", "Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application", "Notice", "60 Day Proposed Information Collection", "2024-11-29T05:00:00Z", 2024, 11, "2024-11-29T05:00:00Z", "2025-01-29T04:59:59Z", "2024-11-29T15:20:43Z", "2024-28036", 0, 0, "090000648683efa4"], ["FDA-2024-D-4643-0001", "FDA", "FDA-2024-D-4643", "Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2024-11-27T05:00:00Z", 2024, 11, "2024-11-27T05:00:00Z", null, "2024-11-27T14:51:02Z", "2024-27804", 0, 0, "090000648683b280"], ["FDA-2018-N-3236-0003", "FDA", "FDA-2018-N-3236", "Advisory Committee; Oncologic Drugs Advisory Committee; Renewal", "Notice", "Notice of Renewal", "2024-11-27T05:00:00Z", 2024, 11, "2024-11-27T05:00:00Z", null, "2024-11-27T15:34:59Z", "2024-27797", 0, 0, "090000648683b12a"], ["FDA-2024-D-4540-0001", "FDA", "FDA-2024-D-4540", "Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2024-11-27T05:00:00Z", 2024, 11, "2024-11-27T05:00:00Z", null, "2024-11-27T15:40:10Z", "2024-27796", 0, 0, "090000648683a82d"], ["FDA-2024-N-2888-0010", "FDA", "FDA-2024-N-2888", "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substantial Equivalence Reports for Tobacco Products", "Notice", "30 Day Proposed Information Collection", "2024-11-26T05:00:00Z", 2024, 11, "2024-11-26T05:00:00Z", "2024-12-27T04:59:59Z", "2024-11-26T15:28:47Z", "2024-27654", 0, 0, "0900006486837e77"], ["FDA-2024-D-2274-0001", "FDA", "FDA-2024-D-2274", "Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices; Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2024-11-26T05:00:00Z", 2024, 11, null, null, "2024-11-26T13:54:19Z", "2024-27661", 0, 0, "0900006486837dfa"], ["FDA-2024-N-2889-0009", "FDA", "FDA-2024-N-2889", "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements", "Notice", "30 Day Proposed Information Collection", "2024-11-26T05:00:00Z", 2024, 11, "2024-11-26T05:00:00Z", "2024-12-27T04:59:59Z", "2024-11-26T15:39:03Z", "2024-27655", 0, 0, "0900006486837e30"], ["FDA-2018-N-0180-0014", "FDA", "FDA-2018-N-0180", "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications", "Notice", "30 Day Proposed Information Collection", "2024-11-25T05:00:00Z", 2024, 11, "2024-11-25T05:00:00Z", "2024-12-27T04:59:59Z", "2024-12-11T02:00:58Z", "2024-27483", 0, 0, "0900006486833a0c"], ["FDA-2023-D-0488-0004", "FDA", "FDA-2023-D-0488", "Orthopedic Non-Spinal Bone Plates, Screws, and Washers\u2014Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2024-11-22T05:00:00Z", 2024, 11, "2024-11-22T05:00:00Z", null, "2024-11-22T14:35:50Z", "2024-27114", 0, 0, "090000648682e4f0"], ["FDA-2024-N-3609-5234", "FDA", "FDA-2024-N-3609", "Development of an Enhanced Systematic Process for the Food and Drug Administration\u2019s Post-Market Assessment of Chemicals in Food; Public Meeting; Request for Comments; Extension of Comment Period", "Notice", "Extension of Comment Period", "2024-11-21T05:00:00Z", 2024, 11, null, null, "2024-11-22T14:23:51Z", "2024-27289", 0, 0, "090000648682b632"], ["FDA-2016-D-2565-0035", "FDA", "FDA-2016-D-2565", "510(k) Third Party Review Program and Third Party Emergency Use Authorization Review; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability", "Notice", "Notice of Availability", "2024-11-21T05:00:00Z", 2024, 11, null, null, "2024-11-21T14:14:28Z", "2024-27085", 0, 0, "090000648682c244"], ["FDA-2024-P-2515-0004", "FDA", "FDA-2024-P-2515", "Determination That FORTESTA (Testosterone) Gel, 10 Milligrams/0.5 Gram Actuation, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness", "Notice", "Determinations", "2024-11-20T05:00:00Z", 2024, 11, "2024-11-20T05:00:00Z", null, "2024-11-20T14:44:01Z", "2024-27103", 0, 0, "090000648682a069"], ["FDA-2024-N-0009-0007", "FDA", "FDA-2024-N-0009", "Statement of Organization, Functions, and Delegations of Authority", "Notice", "General Notice", "2024-11-20T05:00:00Z", 2024, 11, "2024-11-20T05:00:00Z", null, "2024-11-20T14:39:58Z", "2024-27011", 0, 0, "090000648682a0ad"], ["FDA-2024-P-3699-0003", "FDA", "FDA-2024-P-3699", "Determination That IC-GREEN (Indocyanine Green), 25 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness", "Notice", "Determinations", "2024-11-20T05:00:00Z", 2024, 11, "2024-11-20T05:00:00Z", null, "2024-11-20T14:59:40Z", "2024-27090", 0, 0, "0900006486829fdf"], ["FDA-2007-D-0369-2006", "FDA", "FDA-2007-D-0369", "Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability", "Notice", "Notice of Availability", "2024-11-20T05:00:00Z", 2024, 11, "2024-11-20T05:00:00Z", null, "2024-11-21T19:50:01Z", "2024-27048", 0, 0, "0900006486829e19"], ["FDA-2024-N-4604-0001", "FDA", "FDA-2024-N-4604", "Per- and Polyfluoroalkyl Substances in Seafood; Request for Information", "Notice", "Requests for Information (RFI)", "2024-11-20T05:00:00Z", 2024, 11, "2024-11-20T05:00:00Z", "2025-02-19T04:59:59Z", "2025-02-20T02:00:35Z", "2024-27070", 0, 0, "090000648682a61c"], ["FDA-2024-P-4163-0006", "FDA", "FDA-2024-P-4163", "Determination That NOXAFIL (Posaconazole) Delayed-Release Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of\nSafety or Effectiveness; Correction", "Notice", "Correction", "2024-11-20T05:00:00Z", 2024, 11, "2024-11-20T05:00:00Z", null, "2024-11-20T14:53:38Z", "2024-27082", 0, 0, "0900006486829fe2"], ["FDA-2024-N-3110-0002", "FDA", "FDA-2024-N-3110", "Miguel Angel Montalvo Villa: Final Debarment Order", "Notice", "General Notice", "2024-11-20T05:00:00Z", 2024, 11, "2024-11-20T05:00:00Z", null, "2024-11-21T19:48:38Z", "2024-27093", 1, 0, "090000648682a0b2"], ["FDA-2022-N-0150-0013", "FDA", "FDA-2022-N-0150", "Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID\u201319; Availability", "Notice", "Announcement", "2024-11-20T05:00:00Z", 2024, 11, "2024-11-20T05:00:00Z", null, "2024-11-20T14:49:41Z", "2024-27094", 0, 0, "0900006486829fe4"], ["FDA-2024-P-3482-0003", "FDA", "FDA-2024-P-3482", "Determination That JESDUVROQ (daprodustat) Tablets, 1 Milligram, 2 Milligrams, 4 Milligrams, 6 Milligrams, and 8 Milligrams, Were Not Withdrawn\nFrom Sale for Reasons of Safety or Effectiveness", "Notice", "Determinations", "2024-11-19T05:00:00Z", 2024, 11, "2024-11-19T05:00:00Z", null, "2024-11-19T15:23:17Z", "2024-26915", 0, 0, "090000648682768f"], ["FDA-2024-N-3111-0002", "FDA", "FDA-2024-N-3111", "Ivette Maria Portela Martinez: Final Debarment Order", "Notice", "Statutory Debarment", "2024-11-19T05:00:00Z", 2024, 11, "2024-11-19T05:00:00Z", null, "2024-11-19T13:28:57Z", "2024-26912", 1, 0, "0900006486827777"], ["FDA-2023-E-2611-0006", "FDA", "FDA-2023-E-2611", "Determination of Regulatory Review Period for Purposes of Patent Extension; AGILI\u2013C", "Notice", "Determinations", "2024-11-19T05:00:00Z", 2024, 11, "2024-11-19T05:00:00Z", "2025-01-22T04:59:59Z", "2024-11-19T13:37:18Z", "2024-26910", 0, 0, "0900006486827d2d"], ["FDA-2024-N-4860-0001", "FDA", "FDA-2024-N-4860", "Pfizer, Inc., et al.; 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