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 Establishment Inspection Report & Microbial Data – Pharmalab Enterprises Inc. (FEI#3004797270)
Regular price $69.00 USDRegular priceUnit price / per -
FDA MedWatch Report – Elevidys Suspect ADR (Case 24292583: Increased Body Temp, Nausea, Myalgia, Vomiting, Diarrhea)
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FDA MedWatch Reports – 12 Cases (Case IDs: 23884142, 23842792, 23787124, 24141371, 24141367, 24121593, 24121591, 24110722, 24105137, 24079611, 24073979, 24066741)
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FDA AE Correspondence & MedWatch Reports – WINREVAIR™ (sotatercept-csrk) (01NOV24–30NOV24)
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FDA MedWatch Reports – Tacrolimus (Dr Reddy as Manufacturer)
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FDA AE Correspondence & MedWatch Reports – WINREVAIR™ (sotatercept-csrk) (10/01/2024–10/31/2024)
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FDA MedWatch Case Report – Case No. 18507071
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FDA IND 141001 Submission – Complete Contents (Submission No. 0002)
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FDA QAP – Anthea Pharma Private Limited (India; FEI 3026048557; Sangareddy, Telengana 502307)
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FDA QAP – ABRYL LABORATORIES PRIVATE LIMITED (India; FEI 3015793804; Punjab 140507)
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FDA Monthly Counts – INTERACT & Pre‑IND Meeting Requests (January 2022–November 2024)
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FDA Forms 3500/3500A/3500B – Narrative Material for 12 Specified FAERS Case IDs
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FDA Detailed Adverse Drug Reaction Case Information – Beyond Primary FAERS Data
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FDA FAERS Reports – Inflammatory Bowel Disease (Specified Case Numbers)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Individual Case Report Narratives (Not Included in FAERS Dashboard/Quarterly Files)
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FDA FAERS Report – Case ID 23241771
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FDA FAERS Data – Potassium Chloride
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FDA FAERS Adverse Event Records – Tarlatamab-dlle (Imdelltra) for Relapsed Small Cell Lung Cancer
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FDA MedWatch Reports – 12 Serious Botulism Reaction Cases (Case IDs: 22143714, 22269263, 13185709, 17478657, 17676992, 18811907, 19010737, 19021142, 19681503, 20209008, 21138510, 21146773)
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FDA MedWatch Reports – 12 Cases (Repeated Use of AbobotulinumtoxinA & OnabotulinumtoxinA; Case IDs: 6562808, 6562810, 6601297, 6991676, 7437070, 8237683, 8686916, 10387556, 13264711, 14815361, 15879537, 15985755)
Regular price $69.00 USDRegular priceUnit price / per -
FDA FAERS Reports – Izervay (Avacincaptad Pegol) (11/01/2024 to 11/30/2024; Electronic)
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FDA FAERS Report – SYFOVRE/Pegcetacoplan in Ophthalmology (11/01/2024 to 11/30/2024; Electronic)
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FDA FAERS Reports – Five Case Reports (Case IDs: 201056941, 211707642, 211944414, 214648181, 218805231; Request by Kate McQuarrie, Northwestern University)
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FDA FAERS Data – Pegcetacoplan (Syfovree)
Regular price $69.00 USDRegular priceUnit price / per -
FDA FAERS Data – Astellas/Iveric’s Izervay (Avacincaptad Pegol)
Regular price $69.00 USDRegular priceUnit price / per -
FDA FAERS Reports – Amtagvi (Lifileucel) (1/1/24 to 12/10/24; PDF/Excel)
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FDA FAERS Reports – Sarepta’s Elevidys (delandistrogene moxeparvovec-rokl)
Regular price $69.00 USDRegular priceUnit price / per -
FDA FAERS Data – Blueprint Medicines’ Ayvakit (Avaprtinib)
Regular price $69.00 USDRegular priceUnit price / per -
FDA FAERS Reports – Elevidys (Delandistrogene Moxeparvovec-rokl) (1/1/24 to 12/10/24; PDF/Excel)
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FDA FAERS Data – Geron’s Rytelo (Imetelstat)
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FDA FAERS Reports – Iovance’s Amtagvi (Lifileucel)
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FDA FAERS Data – Merck’s Winrevair (Sotatercept)
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FDA FAERS Reports – Rezdiffra (Resmetirom) (1/1/24 to 12/10/24; PDF/Excel)
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FDA FAERS Reports – Zevra’s Miplyffa (Arimoclomol)
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FDA Forms 3500/3500A/3500B – Narrative Material for FAERS Case IDs 22313077, 22266566, 22275100, 22304379, 22190532, 22248178, 22244763, 22235384, 22180097, 22196676, 22138264, 22182403 (Email if Possible)
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FDA Full FAERS Reports – Syfovre/Pegcetacoplan (Nov 23–29, 2024; Electronic)
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