Collection: Fast Track Requests
FDA documents available for fast-track requests typically delivered within 1 to 2 weeks. Our fast-track request service identifies previously requested and redacted documents for quick access.
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FDA Disclosable 483s and EIRs Released to Redica Systems – February 1–28, 2025
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FDA Log of FOIA Requests Denied Under 7(a) Exemption – January and February 2025
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FDA FAERS Reports for Attruby – Request for CSV Format
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FDA Form 483 for La Crosse Milling Co. Inspection Ending May 3, 2023 (FEI 2125677) – Foods and Cosmetic
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FDA Records for NDA019927
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FDA Summary Basis of Approval Documents for NDA N018304 – Chemistry and Admin Reviews
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FDA Request for Previously Released 483s, EIRs, and Responses Under FOIA
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FDA Form 483s, Complaints, and Regulatory Docs on NECC and 2012 Fungal Meningitis Outbreak
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FDA FSVP Entry-Line Records for United Safety Agents – February 1–28, 2025
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FDA Full Case Reports for IDs: 23593688, 23628353, 23498340, 23628270, 23589099, 23561988, 23459843, 23395520, 23503362, 23356071, 23366774, 23960988
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FDA FAERS Adverse Event Reports for WINREVAIR (sotatercept) from Jan–Feb 2025
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FDA Form 483s for Mannkind, Hologic, Sterigenics, and Others – Devices Inspections
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FDA Form 483s for Iotamotion, Randy Hicks, Life Sciences Vandalia, DDC Technologies, and Strata Skin Sciences
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FDA Employee Directory with Full Name, Title, Location, Hire Date, and Email Address
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FDA Labeling for NDA 022276 SUPPL-25 Nicardipine Hydrochloride Injection – August 16, 2024
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FDA Form 483s for Emcure Pharmaceuticals and Laurus Labs Inspections Ending Feb 2025 and Jan 2025
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FDA Form 483 for CSPC Ouyi Pharmaceutical Co., Ltd. (FEI 2000021110)
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FDA CVM Log of FOIA Requests Processed in December 2024
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FDA Form 483s for Vivos Therapeutics, Chemsil, ALOM Tech, Exactech, and Nihon Kohden – Devices
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FDA Form 483 for KBI Biopharma (FEI 3004638264) – September 2020 Inspection Classified OAI
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FDA Form 483 for Angiodynamics, Inc. Inspection Ending Jan 10, 2025 – Devices Compliance
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FDA Form 483 for Heat In A Click LLC Inspection Ending Jan 24, 2025 – Devices Compliance
Regular price $69.00 USDRegular priceUnit price / per -
FDA Form 483 for Keranetics Inc. Inspection Ending Feb 6, 2025 – Devices Compliance
Regular price $69.00 USDRegular priceUnit price / per -
FDA Form 483 for Cardiac Insight, Inc. Inspection Ending Feb 7, 2025 – Devices Compliance
Regular price $69.00 USDRegular priceUnit price / per -
FDA Form 483 for PLZ Corp Inspection Ending Jan 15, 2025 – Drug Quality Assurance
Regular price $69.00 USDRegular priceUnit price / per -
FDA Form 483 for SI Group, Inc. Inspection Ending Jan 17, 2025 – Drug Quality Assurance
Regular price $69.00 USDRegular priceUnit price / per -
FDA Form 483 for Arthrex, Inc. Inspection Ending Jan 13, 2025 – Devices Compliance
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FDA Form 483 for Redicare LLC Inspection Ending Jan 10, 2025 – Devices Postmarket
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FDA Form 483s for Medshift, Spok, PJM World Wide, Life Sciences Vandalia, and Exer Labs – Medical Devices
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FDA Form 483s for Penner Mfg, Angiodynamics, APEX Dental Sleep Lab, Nightware, and JoGo Health – Medical Devices
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FDA Form 483s for Alameda Health System IRB, Westwood Labs, Cambrex, Genzyme, and Morgan Gallacher
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FDA Form 483s for Rnv LLC, DHL Supply Chain, Pharmaceutics Intl, PLZ Corp, and Amrut Ambardekar – Human Drugs
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FDA FAERS Reports on Retinal Vasculitis and All Safety Reports for Izervay and Syfovre
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FDA Request for Documents and Safety Reports Related to Drug Syfovre
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FDA Full Case Details for FAERS Case IDs: 24631070, 24098043, 23027097
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FDA Summary Narratives for Semaglutide FAERS Cases: 24431673, 24556422, 24556421, 24546950, 24566981, 24589385, 24578484, 24616184, 24622224, 24611285, 24644491, 24634599
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