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 Salmonella Outbreak Records – Linked to Cantaloupes
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 for Siegfried Evionnaz SA – Animal Health Inspection – Switzerland (Mar 31, 2023)
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FDA EIR Report for Shandong Xinhua Pharmaceutical Co. – FEI 3002808153 (Sep 15, 2023)
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FDA 483 for Suzhou Suncadia Biopharma – China (Nov–Dec 2023; FEI 3015786877)
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FDA 483 for Suzhou Suncadia Site – China (Nov 30–Dec 15, 2023; FEI 3015786877)
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FDA EIR for Ofichem BV – Request
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FDA Foodborne Outbreak Summary Report – Precut Cantaloupe from Trader Joe’s
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FDA Dexcom Warning Letter – Not Yet Publicly Posted
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FDA VAERS Report – Request
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FDA 483 Warning Letter for Laboratorios Farmaceuticos Rovi – Spain (May 19, 2023; FEI 3010705046)
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FDA Missing Submission Dates for 10 Postmarketing Requirements – Request
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FDA 483 Warning Letter for Dr. Reddy’s Labs – Visakhapatnam, India (May 17, 2024; FEI 3006549835)
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FDA 483 Warning Letter for Excelvision – France (Nov 19, 2024; FEI 3007058211)
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FDA Adverse Drug Events for Journavx – PDF and XLSX Format
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FDA Adverse Drug Events for Yorvipath – PDF and XLSX Format
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FDA 483 for Softgel Healthcare Pvt Ltd – India (Feb 2019; FEI 3006381009)
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FDA RLD Package Insert for Diazepam Injection – NDA N016087
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FDA 483 for Axxelent Pharma Science Pvt Ltd – India (Jun 21, 2024; FEI 3026504963)
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FDA + CDC Salmonella Outbreak Documentation – 2023
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FDA Documents on Cucumber Salmonella Outbreak – Oct–Nov 2024
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FDA Orange Book Exclusivity Evaluation for NDA 217779 – RYTELO (Imetelstat Sodium)
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FDA Exclusivity Summary for NDA 217225 – IZERVAY (Avacincaptad Pegol)
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FDA FAERS Reports for Bimzelx – Jan 2023–Present
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FDA FAERS Reports for Nemluvio – Jan 2023–Present
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FDA FAERS Reports for Jounavax (Suzetrigine) – Jan 2023–Present
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FDA Missing Submission Dates for Postmarketing Requirements – Request
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FDA Summary Basis of Approval for NDA 020472 – ESTRING (Estradiol Vaginal System)
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FDA FAERS Case Reports for Pertzye – Case IDs 24771464 and 24635859
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FDA FAERS Summary Adverse Events for Ayvakit (Avapritinib) – Jan 2023–Present
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FDA FSVP Importer Records – Schreiber Foods, Inc.
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FDA Approval Letter, Citizen Petitions, and Correspondence for ANDA 218628 – Buspirone Hydrochloride
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FDA GMP Status and 483 for Pinnacle Life Science Pvt. Ltd. – Baddi, India
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FDA Adverse Event Line Items for Rytelo – Feb–Mar 2025
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FDA Adverse Event Line Items for Attruby – Feb–Mar 2025
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FDA Adverse Event Narratives – Requested Case IDs (Attached)
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FDA Adverse Drug Event Reports for Rytelo – CSV and PDF Format
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