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 Adverse Event Reports for AK Forte, Infla-650, and Umary
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 for Eone Laboratories, Korea, Inspection Ending 4/9/2019
Regular price $69.00 USDRegular priceUnit price / per -
FDA Supplemental NDA Assessment Report for NDA 207981/012
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FDA 483s for Meritus Medical, New York Cryo - Inspections Ending 5/8/2024, 3/21/2024
Regular price $69.00 USDRegular priceUnit price / per -
FDA CDRH Medical Device Registration Data for California Manufacturers
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FDA Communications with Zoetis Regarding Librela or Bedinvetmab
Regular price $69.00 USDRegular priceUnit price / per -
FDA 510(k) K230372 VITREJECT Full Submission Copy Request
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FDA Cronobacter/Salmonella Investigations into Abbott Similac Batch 51243S600 and Kentucky Infant Cases
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FDA NDA Review Packet for PIVMECILLINAM Including Medical and Chemistry Reviews
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FDA BLA 125504/S-063 Action Package for Cosentyx (Hidradenitis Suppurativa)
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FDA Food Additive Petition for 2-Vinylpyridine-Co-Styrene (FDA–2014–F–0452)
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FDA Health Hazard Evaluation for Mighty Bliss Heating Pads Recall
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FDA 510(k) K203517 and K211733 Full Submissions for DeepHealth and Lunit
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FDA Reviewer Notes for EX0003170.PD1
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FDA 483 for ALBA Bioscience, UK, Inspection Ending 3/17/2023
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483s for Community Fertility, Janssen, BioTek America - Inspections Ending 1/11/2024, 12/14/2023, etc.
Regular price $69.00 USDRegular priceUnit price / per -
FDA Medical and Team Reviews for TUKYSA SUPPL-4 Approval 01/19/2023
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FDA 510(k) K232149 Submission Package and Related Communications
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FDA HYDROXYUREA NDA 075734 Approval/Review Summary Documents
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FDA Tracey Forfa Emails Re: Bird Flu and Livestock (H5N1)
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FDA Records on Kathy Crosby CTP Departure, Recusals, Post-Gov Memos
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FDA De Novo Request for Fetal Pillow (DEN150053) by CooperSurgical
Regular price $69.00 USDRegular priceUnit price / per -
FDA Correspondence with Outlaw Dip Co. Re: Nic-safe, Nixamide Products
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FDA CTP Review Materials for STN EX0002668
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FDA 510(k) K223882 Narrowband UV Phototherapy Lamp by Shenzhen Honpal
Regular price $69.00 USDRegular priceUnit price / per -
FDA 510(k) Predicate Review Request: K093679, K122276, K153500, K160454, K163261, K191413
Regular price $69.00 USDRegular priceUnit price / per -
FDA CTP-Altria Group Correspondence on Modern Oral Nicotine Products
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FDA Communications Re: Donald Prater, Megen Velez with White House
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 for Armed Services Blood Bank Center, Germany, Inspection Ending 8/23/2023
Regular price $69.00 USDRegular priceUnit price / per -
FDA Integrated Review for Voxzogo sNDA 214938/S002 Approval 10/20/2023
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FDA Communications to Teva Re: ANDA 076772 and 076655 (Feb-Apr 2019)
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FDA ANDA 207719 CDER Review of PHYTONADIONE Injectable
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FDA Moderna Contamination Communications with Ranjan, Truong, Verma
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FDA sBLA Multidisciplinary Review for Dupixent (Prurigo Nodularis) Approval 09/28/2022
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 for BioLife Plasma Services, OKC, Inspection Ending 2/13/2020
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 for Tepnel Pharma Services, UK, Inspection Ending 3/11/2019
Regular price $69.00 USDRegular priceUnit price / per