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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below to find the documents you are looking for by common criteria such as name, company, classification, date, etc.Can't find what you are looking for? Submit a Custom Request.
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FDA Full FAERS Reports – IZERVAY/Avacincaptad Pegol Intravitreal Solution (Nov 23–29, 2024; Electronic)
Regular price $69.00 USDRegular priceUnit price / per -
FDA FAERS Reports – Five Additional FAERS Reports (Attached)
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FDA FAERS Case Reports – Case IDs 24239860, 24239858, 24239855, 24239853, 24239850, 24307431, 24239879, 24239871, 24239870, 24239868, 24239863, 24239862
Regular price $69.00 USDRegular priceUnit price / per -
FDA FAERS Case Report – Pertzye (Pancrelipase) with Pertzye as Primary/Secondary Suspect, Case ID 24137236
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FDA Full FAERS Reports – Winrevair/Sotatercept Adverse Events (11/1/2024–11/30/2024, Electronic)
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FDA Full FAERS Reports – Syfovre (Pegcetacoplan) Adverse Events (11/16/2024–11/22/2024, Electronic)
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FDA Full FAERS Reports – IZERVAY/Avacincaptad Pegol Intravitreal Solution (11/16/2024–11/22/2024, Electronic)
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FDA FAERS Case Report – HEMLIBRA (Emicizumab), Case ID 24210494
Regular price $69.00 USDRegular priceUnit price / per -
FDA FAERS Case Reports – Harrow Client (Case IDs: 5506625, 5500923, 5506634, 5506632, 5506629, 5506627, 5332812, 5332811, 5328638, 5327605, 5327601, 5201254)
Regular price $69.00 USDRegular priceUnit price / per -
FDA FAERS Reports – Daybue (Troinetide) Adverse Events (From 1/1/2023; Case IDs: 239240521, 238170541, 237420811, 232756201, 232574331)
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FDA FAERS Reports – Amtagvi (lifileucel) (1/1/2024–12/2/2024 or Latest, Brand & Generic)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Forms 3500/3500A/3500B – Full Narrative Material for FAERS Case IDs: 22708145, 22698307, 22698249, 22690973, 22686962, 22686601, 22678234, 22634625, 22634443, 22393578, 22333502, 22324784
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FDA FAERS Case Report – Oxervate (cenegermin-bkbj) for MAH Dompé farmaceutici S.p.A. (Case 24278461, Received 30-Aug-2024)
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FDA MedWatch Reports – 12 Repeated-Use OnabotulinumtoxinA Cases (Multiple Case IDs; Botox & Botox Cosmetic)
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FDA MedWatch Reports – 12 Serious Botulism Reaction Cases (Multiple Case IDs; Dysport & Botox)
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FDA FAERS Individual Case Reports – Gallium Ga-68 Gozetotide (Case IDs: 24370583, 24110796, 24067412)
Regular price $69.00 USDRegular priceUnit price / per -
FDA FAERS ICSR Source Documents – NAXITAMAB (Q3 2024; Case Nos: 24271071 & 24343373)
Regular price $69.00 USDRegular priceUnit price / per -
FDA FAERS Reports – Syfovre (Pegcetacoplan) Adverse Events (Nov 07–15, 2024)
Regular price $69.00 USDRegular priceUnit price / per -
FDA FAERS Case Reports – Oxbryta (Voxelotor) – Multiple Case Numbers
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FDA FAERS Reports – Retinal Vasculitis for Syfovre (Pegcetacoplan) [Case Nos: 24129218, 24129261, 24134019, 24143045, 24143158, 24149020]
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FDA Request for FAERS Records – leqembi/lecanemab Cases (Multiple Case IDs)
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FDA Zimmer Biomet EIR, 483 & Warning Letter File (01/01/2016–2024)
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FDA Documents & Inspection Records – Listeria Infection, Real Kosher Ice Cream/Ice Cream House LLC (Brooklyn, NY: 2 Church Ave & 3614 15th Ave)
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FDA eCTD Sequence 0001 – Missing Index & Util Folder Files (Chemport Inc.)
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FDA Documents & Correspondence – Counterfeit Ozempic and Semaglutide (Seizure Details & Congressional Response)
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FDA Establishment Inspection Report – Emergent Biosolutions (Janssen Covid Vaccine, Drafted 05/14/2021)
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FDA Establishment Inspection Report – Rovi Pharma Industrial Services S.A. (Madrid, Spain; FEI 3016688535, End ~09/22/2023)
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FDA Re‑Issued EIR – Site with FEI 3030047446 (Inspection Completed 05 Feb 2024; Original EIR Date 25 Apr 2024)
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FDA Disclosable Redacted EIRs (PDF) – Released Since November 1, 2024 (Excluding Redica Systems)
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FDA EIR – Fresenius Kabi Oncology Limited, India (FEI 3003519498)
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FDA EIR – Alcami Charleston, SC Inspection (Conducted 4/1–5/24)
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FDA EIR – Drug Inspection of Styrax Life Sciences Private Limited (Ended 06/07/2024; Andhra Pradesh, India; FEI 3018393466)
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FDA Electronic Inspection Reports (EIRs) – Curia Indiana (FEI 3001452090, 3065 Kent Ave, West Lafayette, IN 47906; Inspections on 09/08/2023 [ID 1219559] and 06/25/2015 [ID 932074])
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FDA EIR Summary – Huzhou Zhanwang Pharmaceutical Co., Ltd (FEI: 1000613242)
Regular price $69.00 USDRegular priceUnit price / per -
FDA EIR Report / 483 Summary – s8304 BIOTIKA (FEI: 3003370212, Drug Quality Assurance, Ending 01/06/2018)
Regular price $69.00 USDRegular priceUnit price / per -
FDA EIR Report – M9083 Wuhan Wuyao Pharmaceutical Co., Ltd. (FEI: 3010686159, Drug Quality Assurance, Ending 09/03/2018)
Regular price $69.00 USDRegular priceUnit price / per