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 – Luspatercept (2024)
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FDA Adverse Event Reports – Serious Cases for Spravato (2024; ~5,382 Cases)
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FDA Adverse Event Reports – Serious Cases Labeled "Ketamine" (2024)
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FDA Adverse Event Reports – Serious Cases Labeled "Ketamine Hydrochloride" (2024)
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FDA Records & Correspondence – MAUDE AE Report MW5112084 for Bausch & Lomb Trulign Toric Lens (2023–2024)
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FDA Electronic Response Letters – AstraZeneca Gaithersburg Plant Inspection (FEI 1000198729)
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FDA Inspection Records – Boehringer Ingelheim Fremont, Inc. (FEI: 3005925062; Oct 25–Nov 24, 2022 & May 8–16, 2024)
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FDA Judge Rotenberg Educational Center Inc – Aversive Therapy & DVCS Letters, Warnings, and 483 (2010–2012)
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FDA Labeling & Package Inserts – Document CR170160 (Parent DEN170019)
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FDA News Communications – Regulation of Paragard (Complete Communications with Spotlight on America and CBS12 News I-Team)
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FDA Export Certificates – IFIT PROSTHETICS LLC (Registration Number 3012266277; FEI 3012266277; Active)
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FDA Review & Compliance Records – Medical Device Evaluation, Cybersecurity, SOPs, Procurement, Statistics, and Oversight
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FDA Transcript – Meeting on Epidemiology Research Needs Related to Radiofrequency Energy from Wireless Phones (April 18–19, 2001)
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FDA Full Transcript – August 1, 2000 Public Meeting on Wireless Technology Research & Radiofrequency Energy Effects on Micronucleus Formation
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FDA CDRH & Allegation Team Investigation – Breast Implant Safety Alliance & Dr. Babak J. Mehrara (March 4, 2023)
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FDA Records on Radiation-Emitting Devices – Stereotaxis, Inc. Communications & 21 CFR Part 1002 Exemption (Feb 6, 2002)
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FDA OTN Implants B.V. – Custom Device Annual Filings & Inspection Records (2018–2021)
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FDA DePuy Synthes Urgent Medical Device Removal Notice – Articul/eze Femoral Heads (05/12/2021)
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FDA CDRH Complaint File for DePuy Orthopedics – FDA-SB-CPT2102099 (2022–2024)
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FDA Scientific Review & Risk Documents for Sec. 690.800
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FDA Breakthrough Designation Submission for SmartFuse® – Intelligent Implants LLC (2021–2024)
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FDA Documents & Investigations on PE-PUR Foam (2021–2024)
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FDA Records on Prilosec & Nexium (2020–2024)
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FDA Request for H1000 Series Tube Housing (2020–2024)
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FDA 3M Forced Air Warning Device & Health Provider Letter Recommendations (01/01/2016–06/25/2018)
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FDA Design History File for Essure Sterilization Device – Conceptus Inc & Bayer (2017–2024)
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FDA Judge Rotenberg Education Center Inc – Electrical Stimulation Devices Meetings & Communications (2012–2024)
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FDA Expert Opinions on Electrical Stimulation DVCS – Drs. Smith, Lavigna & Brown (2016–2024)
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FDA Electronic EIR & 483 – Medtronic Navigation, Inc. Inspections (03/14/2017 & 09/30/2019)
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FDA EIR – DEVICE Facility Inspection of Sterigenics (Charlotte, NC; 24–25 Oct 2022; FEI 1000219637, DUNS 883864076, HC REF 500458)
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FDA Signature Orthopaedics USA Corp. – Custom Device Filings & Inspection Records (‘Patriot’ Implant, 2018–2021)
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FDA De Novo Submission – DEN230003 (Viz.ai, Inc., Viz HCM)
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FDA De Novo Submission – DEN200064 (Files & Correspondence)
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FDA De Novo Grant Documents – Photon Instant Biological Indicator (DEN220042, Approved 07/12/2024)
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FDA De Novo Submission Files – DEN200064 and Correspondence
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FDA Warning Letters Spreadsheet – Firms (10/01/2011–10/31/2024, Detailed Contact & Issuance Information)
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