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 Inspection Logs in Excel Format for Inspections October 1, 2024 to February 27, 2025
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FDA Outsourcing Facility Drug Product Reports June to November 2024 Submitted in December 2024
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FDA Form 483 for Amneal Oncology Pvt Ltd – November 17, 2023, Hyderabad, India (FEI 3005903939)
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FDA Tentative Approval Letter for ANDA 214370 Rifaximin – Dated January 10, 2025
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FDA Adverse Event Reports on DAYBUE (trofinetide) and Nuplazid (pimavanserin) from January 1, 2023
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FDA FAERS Case Reports on Xofigo (radium Ra 223 dichloride) – Academic Request (Fifth Submission)
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FDA Form 483s for Quadric BioMed, Dharma Research, Murata Vios, and Others – December 2024 Inspections
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FDA Staff Manual Guide 4850.7
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FDA Form 483s for Ceevra Inc., Sac LLC, and Others – Medical Device Inspections Ending August 2024
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FDA CSV Inspection Report Listing May 26 – November 26, 2024 Including CPGM Product Assignment Code
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FDA CSV Listing of RRAs Conducted Since August 26, 2024
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FDA Inspection Logs and Citations in CSV Format Since February 26, 2024
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FDA Capvaxive (BLA 125814) Review Documents Including Summary Basis and Multiple Memoranda
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FDA Form 483 for Glenmark Pharmaceuticals (FEI 3008565058) Inspection February 2025 – Pithampur, India
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FDA Adalimumab Cases with Primary Sclerosing Cholangitis – Multiple Case IDs
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FDA Labeling for ERYCETTE (erythromycin pledgets) NDA 050594
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FDA Form 483s for Western Reserve Health Education IRB and Central Solutions Inc – Drug Inspections
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FDA Preliminary Comments for Zolbetuximab.clzb (BLA 761365) February 7, 2023 and June 15, 2020
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FDA Form 483s for Herman Ayvazyan, AACE Pharmaceuticals, and Others – Drug Inspections
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FDA FAERS Case Reports for Leqembi (lecanemab) – Multiple Case IDs Requested
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FDA Form 483s for PLZ Corp, Amrut Ambardekar, and Others – Drug Inspections Ending January 2025
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FDA EIR for CHENGDA PHARMACEUTICALS (FEI 3004248447) – November 2024 Inspection
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FDA EIR for HUZHOU ZHANWANG PHARMA (FEI 1000613242) – March 2024 Inspection
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FDA EIR for Deccan Nutraceuticals Pvt Ltd (FEI 3007607026) – April 2023 Inspection
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FDA Form 483 and EIR for Zydus Lifesciences (FEI 3013712903), Gujarat, India – April 2024 Inspection
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FDA Case ID Reports Including 23668380, 24332693, 24189459, 24350154, Etc.
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FDA FAERS Individual Case Report Request – Grastek Case 24344877
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FDA MedWatch Reports for 12 Cases Including IDs 24201332, 24195867, 24362404, Etc.
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FDA Litigation Releases to Protect the Public’s Trust
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FDA VAERS Records Request
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FDA Investigation Records Related to Similac NeoSure Batch 29996RE00 and Cronobacter Case in Illinois
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FDA Investigation Records Related to Similac NeoSure Cronobacter Contamination – Batches 48117RE347, Etc.
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FDA EIR for Becton Dickinson (FEI 1119779) Inspection July 19-23, 2021 at Sparks, MD Facility
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FDA EIR for Inspection of Caitlin C. Meyer, M.D. (FEI 3024668889), North Miami, Florida
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FDA Records on 2024 E. coli O157:H7 Outbreak Investigation – CDC ID: 2411MOEXH-2
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FDA Form 483s for Keranetics Inc., Angiodynamics Inc., and Others – Medical Device Inspections
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