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 Reports for Ayvakit – Request for CSV Format
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FDA Warning Letter to Dexcom Dated March 4, 2025
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FDA Bioequivalence Study Data – Alembic Midodrine HCl 5mg (NDC 62332-339-31) – Plasma Profiles
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FDA Outsourcing Facilities Reports for H2 2024 – Semaglutide and Tirzepatide
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FDA 483 for Shiva Analytics Pvt. Ltd. – Human Drug Inspection Feb 2025 (FEI 3006192929)
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FDA 483s for Japanese Companies: Sakai Chemical, Kaneka Takasago, Bushu Pharmaceuticals
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FDA Promotional Materials Review Using Meta-Research – Consistency with Labeling Guidance (CFL)
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FDA 483s for Dexcom Inc. – San Diego and Mesa Facility Inspections in 2024
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FDA Medication Error Review for NDA 018680 Paragard – Memorandum Dated Dec 23, 2022
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FDA 483 for Sunshine Lake Pharma Inspection Ending Mar 22, 2024 (FEI 3007721552)
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FDA 483 Reports for Gruma Corp, Americold Logistics, Jubilant Cadista – January 2025
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FDA 483 Reports for Pharmavite, Taisun Enterprise, Gategourmet – January 2025
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FDA 483 Reports for Angiodynamics, Frontage, Lepage Bakeries – January 2025
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FDA FAERS Reports for COBENFY (Xanomeline + Trospium) – Jan 1 to Mar 7, 2025 – CSV Requested
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FDA Presentation: Regulatory Perspective on Human Milk Bioactives – March 4, 2025 – Kotaro Kaneko
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FDA Site Inspection Results at Anderson Inc. Customer Facility – Permethrin and Chlorpropham Detected
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FDA 483 Reports for Nuvalent, Inc. and Affiliated Facilities – Full Set Requested
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FDA Bioequivalence Review Memo for ANDA 215719 – Loteprednol Etabonate Ophthalmic Suspension
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FDA Chemistry & Toxicology Review Memoranda for FCN 2297
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FDA 483 for ICU Medical Facility in Austin, TX – Issued Sep 24, 2024 (FEI 1628454)
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FDA Comments Submitted to Docket No. 85N-0483 – 56 Fed. Reg. 3338 (Jan. 29, 1991)
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FDA Approved Labeling for ANDA 088811/SUPPL-26 – Action Date Jun 3, 2016
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FDA 483 for Baxter Oncology GmbH Inspection Aug 19–27, 2024 (FEI 3002806419)
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FDA 483 for Covance Pharmaceutical R&D (Shanghai) Inspection Ending Jul 24, 2015 (FEI 3011542813)
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FDA 483 for West China-Frontier Pharma Tech Inspection Ending Apr 21, 2017 (FEI 3010186278)
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FDA FOIA Productions Under America First Legal Foundation Lawsuit – Feb 1–28, 2025
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FDA Routing Summary for ANDA 203857 – Glatiramer Acetate Injection 20 mg/mL
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FDA PMRs and PMCs Missing Submission Dates – Request for Additional Data
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FDA 483 for AstraZeneca Pharmaceuticals LP Inspection Ending Jun 7, 2024 (FEI 3002617771)
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FDA 483 for Wyeth BioPharma (Pearl River) Inspection Ending Mar 17, 2017 (FEI 2410662)
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FDA 483 and EIR for Wyeth BioPharma (Andover) Inspection Ending May 3, 2019 (FEI 1222181)
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FDA 483 and EIR for UCB Pharma S.A. Inspection Ending Feb 4, 2022 (FEI 3003909356)
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FDA 483 for Shire Human Genetic Therapies Inspection Ending Mar 23, 2022 (FEI 3009340644)
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FDA 483 for Fresenius Kabi Austria Inspection Ending Mar 28, 2023 (FEI 3003708554)
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FDA 483 for Norbitec GmbH Inspection Ending Apr 6, 2023 (FEI 3010763764)
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FDA 483 for Eli Lilly and Company Indianapolis Inspection Ending Oct 6, 2023 (FEI 1819470)
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