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.
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 Medical Review – Tepezza (teprotumumab), BLA 761143/S-024
Regular price $69.00 USDRegular priceUnit price / per -
FDA EIR – Pharmalab Enterprises Inc., Miami Lakes, FL
Regular price $69.00 USDRegular priceUnit price / per -
FDA Form 483 and Response – Rovena Reagan Women’s Health Care
Regular price $69.00 USDRegular priceUnit price / per -
FDA Warning Letters – FEI Numbers Listed (2000–2023)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Form 483 – ROSLIN CELL THERAPIES LIMITED, August 2023
Regular price $69.00 USDRegular priceUnit price / per -
FDA Food Contact Notifications – Octadecanoic Acid Derivatives
Regular price $69.00 USDRegular priceUnit price / per -
FDA Log of Form 483 Issuance – September 2024
Regular price $69.00 USDRegular priceUnit price / per -
FDA Consumer Complaint – Tulkoff Food Products, Complaint ID 177075
Regular price $69.00 USDRegular priceUnit price / per -
FDA Adverse Event Reports – Librela (Bedinvetmab) in Dogs
Regular price $69.00 USDRegular priceUnit price / per -
FDA Redacted 483 – ICU Medical (Austin, TX) 09/09/2024–09/20/2024
Regular price $69.00 USDRegular priceUnit price / per -
FDA Summary Basis of Approval – Glatiramer Acetate Injection A206873
Regular price $69.00 USDRegular priceUnit price / per -
FDA Recalls by Listed FEI Numbers – 2000 to 2023
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FDA Consumer Complaint Records – Attached Document Case
Regular price $69.00 USDRegular priceUnit price / per -
FDA Case Files Related to James Gary Davidson
Regular price $69.00 USDRegular priceUnit price / per -
FDA ANDA 215808 Approval Letter & SBA – Ketamine Hydrochloride Injection
Regular price $69.00 USDRegular priceUnit price / per -
FDA Updated Inspections, Outcomes & RRAs (12/1/2023–Present)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Modified Enforcement Report Data with FEI & Product Code Info
Regular price $69.00 USDRegular priceUnit price / per -
FDA EIR – Covance Laboratories, Inc. June 2015 (FEI 2128592)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Fast Track Designation Records – Belatacept (Nulojix), BLA 125288
Regular price $69.00 USDRegular priceUnit price / per -
FDA Email and Attachment Sent by Atul Saran on April 19, 2021
Regular price $69.00 USDRegular priceUnit price / per -
FDA 510(k) Documentation – K102965
Regular price $69.00 USDRegular priceUnit price / per -
FDA Entry Documentation – Entry Number 202-2985671-9
Regular price $69.00 USDRegular priceUnit price / per -
FDA Inspection Records – BPI Labs LLC (FEI 3015156709)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Contract Documents – Booz Allen Hamilton IT Needs for Lab Ops
Regular price $69.00 USDRegular priceUnit price / per -
FDA Documents on Turmeric and Liver Toxicity – August to September 2024
Regular price $69.00 USDRegular priceUnit price / per -
FDA Bioequivalence/Chemistry Summary – ANDA 214322
Regular price $69.00 USDRegular priceUnit price / per -
FDA No Objection Letters – Starlinger Recycling Process PNC#958 & PNC#1668
Regular price $69.00 USDRegular priceUnit price / per -
FDA Safety Data on 21 CFR 172.834 Ethoxylated Mono- and Diglycerides
Regular price $69.00 USDRegular priceUnit price / per -
FDA Form 483 and EIR – Samsung Biologics Inspection July 2024
Regular price $69.00 USDRegular priceUnit price / per -
FDA Drug Inspection Reports for Arkema, Inc. (Memphis and Piffard)
Regular price $69.00 USDRegular priceUnit price / per -
FDA NADA #097-222 and #108-114 Records Request
Regular price $69.00 USDRegular priceUnit price / per -
FDA Food Contact Notification FCN 2353 Documents Request
Regular price $69.00 USDRegular priceUnit price / per -
FDA Internal Documents – Paraxanthine
Regular price $69.00 USDRegular priceUnit price / per -
FDA Recall Classification Request – Buprenorphine Recall
Regular price $69.00 USDRegular priceUnit price / per -
FDA Import Alert Report – Swiss Chard (Ferme M & M Lando)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Approval – Mounjaro (tirzepatide) S-002 Human Factors
Regular price $69.00 USDRegular priceUnit price / per