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 MedWatch Report for Case 24737757 – Drug: Vabysmo
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FDA Lab Test Report for Walgreens Acne Treatment Cream – Lot 4970743C, Benzene Content 5 ppm
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FDA Form 483s for Next Science LLC Including Sept 5, 2024 (FEI 3012271775)
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FDA FAERS Reports – Additional 12 Selected Cases with Medical History and Imaging (Endemic Mycoses)
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FDA MedWatch Reports for 12 Cases of Repeated Use of Botox from FAERS Database
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FDA MedWatch Reports for 12 Botulism Cases Related to Botulinum Toxin Type A and Botox
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FDA FAERS Case Reports for Ayvakit: 24743050, 24744011, 24744069, and Others
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FDA FAERS Case Reports for Ayvakit: 24756931, 24769317, 24774340, and Others
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FDA Form 483 for Sterilmed, Plymouth, MN Inspection Issued May 22, 2024
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FDA FOIA Records Related to Byte or Byte Aligner Products from Jan 1, 2019 to Present
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FDA Form 483 for Dr. Reddy’s Laboratories Ltd (FEI 3014250111) Inspection Ending Oct 12, 2023
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FDA Form 483s for Reproductive Technologies, CSL Plasma, and Others – Biologics Inspections
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FDA Form 483s for Westwood Labs, Alameda Health IRB, Jewish Hospital IRB, and Others – Human Drugs
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FDA FAERS Adverse Event Reports for Ayvakit – Request for CSV Format
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FDA Decision Memorandum on Semaglutide Shortage Resolution – February 21, 2025
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FDA Adverse Drug Event Reports for Rytelo from Geron Corp – CSV Format
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FDA Form 483s, Responses, and EIRs for SOFIE Co (FEI 3008415560) from 2015 to Present
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FDA Form 483s for Hubei Yitai, Baxter Thailand, and Others – Drug Quality Assurance Inspections
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FDA Contact Information Request for HHS FDA Employees by Financial Literacy Advocates
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FDA FAERS Reports for Pyrukyn from Jan 1, 2021 to Mar 3, 2025
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FDA FAERS Reports for Treprostinil (TYVASO DPI) from Jan 1, 2024 to Mar 3, 2025
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FDA FAERS Reports for Korlym (mifepristone) from Jan 1, 2024 to Present
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FDA Correspondence and Inspection Records for BioTelemetry Inc. from Jan 1, 2024 to Present
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FDA Immunogenicity Study Documents for ANDA 215503 (LIRAGLUTIDE) Approved Dec 23, 2024
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FDA Human Factors Study Documents in Summary Basis of Approval for ANDA 215503 (LIRAGLUTIDE) Approved Dec 23, 2024
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FDA Approval Letter for ANDA 215503 (LIRAGLUTIDE) Approved Dec 23, 2024
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FDA Approval Routing Summary for ANDA 215503 (LIRAGLUTIDE) Approved Dec 23, 2024
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FDA Summary FAERS Report for WINREVAIR (sotatercept) for PAH Indication
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FDA FAERS Reports on IZERVAY (avacincaptad pegol) – Nov 30, 2024 to Mar 3, 2025
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FDA Form 483 for Acella Pharmaceuticals Inspection Ending Dec 18, 2024 (FEI 3006691461)
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FDA FAERS Reports on IZERVAY (avacincaptad pegol) – Jan 1, 2024 to Mar 3, 2035
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FDA FAERS Reports on SYFOVRE (pegcetacoplan) – Jan 1, 2024 to Mar 3, 2025
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FDA MedWatch Reports for 12 Cases Including 24066739, 24278334, 24243691
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FDA Form 483s for Mylan Laboratories Limited Sinnar, India – Human Drugs Inspection May 2024
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FDA Approval Package for ANDA 207719 – Phytonadione Injectable Emulsion Approved May 22, 2019
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FDA FAERS Reports for Journavx – Request for CSV Format
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