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 Adverse Drug Event Reports for iDose TR – CSV and PDF Format
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 for Dexcom San Diego Inspection Ending Nov 7, 2024 – 7 Observations
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FDA Inspection Records for Glenmark Pharmaceuticals Ltd. – FEI 3008565058
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FDA Individual Adverse Event Reports – Case IDs 20814407 and 21290234
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FDA Approval Package for COSENTYX BLA 125504/S-063 – Hidradenitis Suppurativa (Oct 31, 2023)
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FDA 483 and Inspection Documents for Clinical Investigator Leila Chaychi, MD – Feb–Mar 2024
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FDA Adverse Event Reports by Hims & Hers – Semaglutide and Tirzepatide (Jan–Mar 2025)
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FDA Adverse Event Summary for Tyvaso, Tyvaso DPI, and Korlym (Mar 2025)
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FDA 483 for Octapharma Plasma Inc – Amherst, NY (Jun 2, 2023)
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FDA 483 for Harvest Commodities Marketing, Inc. – Ardsley, NY (Dec 20, 2023)
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FDA 483 for Royal Food Import Corporation – Hollis, NY (Jan 12, 2024)
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FDA FAERS Data Request for Neffy – ARS Pharmaceuticals
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FDA Bioequivalence Discipline Review for ANDA 210317 – Octreotide Acetate Injection (TEVA)
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FDA 483 and Warning Letter for Dr. Reddy’s Laboratories – Andhra Pradesh, India (Aug 2024)
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FDA 483 and Warning Letter for Estee Lauder NV – Belgium (Apr 2024)
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FDA FSVP Audit Documentation for Toshoku America – March 7, 2025
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FDA 483s for Vitrolife, Remel, Arnold Tuber, Soulaire, Beckman Coulter – Medical Devices Inspections Dec 2024–Feb 2025
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FDA 483s for Park Dental, Lingraphicare, FloSpine, Insightra Medical, Medin Technologies – Medical Devices Inspections Jan–Feb 2025
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FDA CVM Calendar Records for Charlotte Conway (Feb 2023)
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FDA 483s for Sports Tek Medical, A Plus Phlebotomy, Memorial Hospital, Lions Eye Bank, NYU Langone – Biologics Inspections Jan–Feb 2025
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FDA 483 for Emcure Pharmaceuticals Ltd. – Kurkumbh, India
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FDA Review Documents for Cosentyx Approval in Hidradenitis Suppurativa (2023)
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FDA Adverse Event Summary for Tums, Tums Ultra, Tislelizumab, Capivasertib, Foscarbidopa/Foslevodopa, and Infliximab-dyyb (Jan–Mar 2025)
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FDA Adverse Event Line Items for Elevidys
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FDA Adverse Event Line Items for Amvuttra and Winrevair – Full Data Requested
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FDA Inspection Records Request – Kaiser Permanente Oakland – Vascepa Study – Aug–Sep 2024
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FDA FOIA Request for Nitrous Oxide Inhalation Adverse Events – Jan 2020 to Present
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FDA 483s and Warning Letters for Applied Therapeutics and Soleno Therapeutics – Jan 2024–Mar 2025
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FDA 483s for Samsung Bioepis, Bio-Thera Solutions, and Others – Biologics – Late 2024
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FDA DMF Records for DMFs 036000, 036001, and 036002 – eCTD Format Requested
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FDA 483s for Certified Labs, Melamed MD, MSI Express, Davion Inc, Karachunski MD – Jan 2025
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FDA 483 and Warning Letter for Dexcom – Inspection March 4, 2025 (FEI 3004753838)
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FDA Advisory Committee Meeting Video Request – QNEXA (Topiramate/Phentermine) – Feb 22, 2012
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FDA Summary Basis of Approval for NDA N01228 – Robaxisal (Approved Before 1982)
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FDA Toxicology, Pharmacokinetics, and Carcinogenicity Data for Chloroquine Injection
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FDA 483 and Response for Microbac Laboratories Inspection Ending Jan 24, 2025 (FEI 3010551507)
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