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 Approval – Wegovy (NDA 215256/S-11)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Approval – Potassium Acetate Injection (SUPPL-11)
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FDA Approval – Potassium Acetate Injection (SUPPL-12)
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FDA Field Alert Report Summary – Jan 2022 to Present
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FDA Document Request – FDA Visitor Logs
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FDA Approval – Varenicline Tablets ANDA 216723
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FDA Approval – Varenicline Tablets (Zydus)
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FDA De Novo Summary – DEN200080
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FDA Approval – Wegovy (SBA, NDA 215256/S-11)
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FDA Form 483 – Establishment Labs Costa Rica
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FDA 510(k) – K870817
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FDA De Novo Summary – Eroxon (DEN22078)
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FDA Field Alert Report Summary – Sun Pharmaceutical (Halol Site)
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FDA Priority Review Voucher List
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FDA 510(k) – K955063
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FDA Document Request – Cleaning Agents for HomeChoice (K102936)
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FDA 510(k) – K023083
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FDA Document Request – Compounded Drug Volume (Dr. Murphy)
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FDA 510(k) – K221623
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FDA Approval – Mallinckrodt EVOLVE
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FDA 510(k) – Rika Plasma Donation System (BK231035)
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FDA Document Request – HPAI Milk Safety Reports
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FDA 510(k) – K912061
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FDA Document Request – AAFCO Emails (Steven Allen)
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FDA 510(k) – K002837
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FDA Inspection Report – OC Raw Dog LLC
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FDA Document Request – AI & Vaccine Communications (Justin Matthew)
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FDA Document Request – Dignicap Clinical Use Protocols
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FDA Document Request – Sean Duke Calendar Records
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FDA Inspection Report – Regeneron Ireland
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FDA Form 483 – BPI Labs LLC
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FDA FAERS Report – IZERVAY (Nov 7–15, 2024)
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FDA Form 483 – API Manufacturing Facility (CTO-2)
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FDA Form 483 – Advanced Accelerator Applications USA (27 Jun 2024)
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FDA Form 483 – Advanced Accelerator Applications USA (03 Nov 2022)
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FDA Form 483 – Advanced Accelerator Applications USA (09 Nov 2021)
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