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 FAERS Report Narratives for Ayvakit – Safety Report IDs 23194051 through 24782612
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FDA FCN Document Request for FCN 966 and FCN 1849 – Full Files and Communications
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FDA 483s for Vynacron Dental Resins, Medical Illumination Intl and Others – Medical Devices – January 2025
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FDA 483s for AEI Technologies, Nemcomed, and Others – Medical Devices – January 2025
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FDA 483s, Warning Letter, and Communications for Dexcom Inspections – Mesa and San Diego (Jun 2024 – Mar 2025)
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FDA Inspection Records Request for Kenny’s Candy & Confections – From March 12, 2020
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FDA Adverse Event and Chemical Data for Amoxicillin – Full Safety and Toxicology Records
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FDA Summary Basis of Approval for NDA 016199 – Cortenema (Hydrocortisone) Rectal Suspension
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FDA FAERS Case Report for DUVYZAT – Case ID 24742539
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FDA FAERS Case Report for Leqembi – Case ID 24226589
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FDA Frequently Requested Records (3+ Requests) List and Copies – Jan 2023 to Jan 2025
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FDA Draft Product-Specific Guidance on Semaglutide – March 2020
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FDA GRAS Dossiers and FDA-Notifier Correspondence for GRNs 1184, 1191, 1171 and Fermify
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FDA Shelf Life and Impurities Specs for Zydus Nelarabine Injection NDC 70710-1726-1 and 70710-1839-1
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FDA EIR Report for South Coast Baking Company – Visit Dec 18, 2024
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FDA 483 for Accrete Pharmaceuticals Inspection Ending May 16, 2018 (FEI 3011918002)
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FDA Bioequivalence Review for ANDA 209728 Approved Jan 13, 2025
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FDA Forms 3500, 3500A, 3500B for 12 Case IDs from FAERS Public Database
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FDA RLD Labeling Request for NDA 019443 – Sodium Bicarbonate in Plastic Containers – Abbott
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FDA Chemistry Review Package for ANDA 073263 – CHOLESTYRAMINE Powder
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FDA Food Safety Records Request for Taste of Nature, Inc. – Melrose Park, IL
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FDA 483 for Brigham and Women's Hospital RDRC Inspection Ending Sep 19, 2019 (FEI 3015196856)
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FDA Food Safety Records Request for Taste of Nature, Inc. – Santa Monica, CA (FEI 3004867962)
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FDA 483 for Excelvision Inspection Ending Nov 19, 2024 (FEI 3007058211)
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FDA MedWatch Reports and AE Correspondence for WINREVAIR (sotatercept-csrk) – Dec 2024–Feb 2025
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FDA Label Request for NDA 203168 Prolensa 0.07% (Bromfenac) – Lupin Pharmaceuticals
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FDA 483s for Endo USA and Synchrony Labs Inspections Ending Jan 17, 2025
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FDA 483 for Paradox Inc Inspection Ending Oct 11, 2024 (FEI 1927976)
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FDA 483 for Softgel Healthcare Pvt Ltd Inspection February 2025 (FEI 3006381009)
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FDA Historical Records Request on Chemicals, Supplements, Monsanto, Accountability
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FDA 483 for Dexcom Mesa Facility Inspection Ending June 14, 2024
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FDA 483s for Scapa Tapes, Baxter Guangzhou, Zhejiang Tianyu – Drug Quality Assurance
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FDA FAERS Report Narratives for Ayvakit – Safety Reports Including 23020097 to 24401579
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FDA 483s for Janssen, Alexion, Concentrics Research – Drug Inspections Late 2024–Jan 2025
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FDA 483 for FUJIFILM Diosynth Biotechnologies Denmark Inspection Ending Nov 12, 2024 (FEI 3006339887)
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FDA 483s for Carolina Infusion, Cetylite Industries, and Others – Human Drugs
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