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 Request for Case IDs – 22897455, 21268575, 232252581, 229699371, 223038123
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FDA Request for Case IDs – 226575621, 233193631, 227589851, 226571381, 233195381, 200799841
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FDA Request for Harrow Eye Cases – Case Nos: 5508172, 5508175, 6076452, 6093079, 6479069, 9292866, 11281806, 11324338, 11426130, 11678609, 12484704, 12886231
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FDA Meeting Materials – Jeffrey Shuren on GRAIL & Multi-Cancer Early Detection (June 22, 2023)
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FDA CDRH Ombudsman’s Dispute Tracking System (2023–2024)
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FDA Communications & Alerts with Amazon.com Inc. – FDA Letter to Andy Jassy (07/26/2021)
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FDA Allegation & Investigation Outcome – ‘Attention’ Letter CPT1900639 (2022–2024)
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FDA Recommendations on Tamper-Evident OTC Packaging (2018–2024)
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DKT FDA-2016-N-1111
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FDA Email Communications – Dr. Stanislaw Burzynski Clinical Trials (01/01/2016–05/19/2016)
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FDA Decision Summary – de novo DEN230076
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FDA CSV Listing of Releasable CITATIONS from FACTS Database (07/01/2024–10/31/2024)
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FDA Records – Hyvisc for Equine Osteoarthritis (Clinical Trial Endpoints, Efficacy, Safety, etc.)
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FDA CVM Records – Inquiry & Correspondence on Unapproved Drugs (Dr. Jodi Lovejoy, Indiana Veterinarians’ Blood Bank, Jan–Feb 2024)
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FDA AERS – Neffy by ARS Pharmaceuticals Inc. (From 1/1/24; PDF/Excel; Investment FOIA)
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FDA AERS – Ojemda (Tovorafenib) by Day One Biopharmaceuticals (From 1/1/24; PDF/Excel; Investment FOIA)
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FDA FOIA Request 2024-3541 – MDO Letter and TPL Review for Shenzhen Yibo Technology Co. Ltd. (Referenced April 15, 2024)
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FDA FOIA Request 2024-3638 – Technical Project Lead Reviews for CTP’s Marketing Denial Order to Shenzhen Yibo Technology Co. Ltd. (April 15, 2024)
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FDA CTP Office of Science Reviewer Summaries & TPLs – STN EX0002447 (2023–2024)
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FDA Communications – The Mellman Group’s Poll on Public Support & Electoral Impact of the Menthol Rule (From February 1, 2024; Robert Califf)
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FDA CTP & HHS/CDC Communications on Marijuana Schedule Classification (2023–2024)
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FDA PRIVATEER Product Series – GOLD, MENTHOL & RED (2oz Formats)
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FDA Contract with McKinsey & Co. – Center for Tobacco Products Innovation (75F40119F19017, 2020–2024)
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FDA Remote Regulatory Assessment & Inspection Reports – Vuse Vibe PMTAs (PM0000635–643)
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FDA Sever Pharma Solutions Inspection – Malmo, Sweden (FEI 3004620701; Inspection ID 1204531; End Date 03/31/2023; Drug Quality Assurance – Drugs)
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FDA FOIA Request – Solvay France S.A.’s Drug Master Files (DMF 8738, 11383, 17709)
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FDA FOIA Requests Log – All Requests Denied/Partially Disclosed Under Exemption 7(A)
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FDA Inspection Form – Dr. Reddy's Laboratories Limited (Unit II) at Bollaram, India (FEI 3005448030; Ended 11/19/2024)
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FDA Response Letters & Communications – Warning Letter 656489 (Azurtity Pharmaceuticals, Inc.)
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FDA Correspondence – Warning Letter for Greenbrier International Inc. dba Dollar Tree (MARCS-CMS 574706)
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FDA Warning Letter – Indoco Remedies (FEI 3005124189)
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FDA Granules India Ltd – Gagillapur Facility Inspection Status (08-26-2024 to 09-06-2024; 6 Observations; Import Alert/Warning Letter Status)
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FDA BD Carefusion Warning Letter – Copy Issued November 2024
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FDA Complete VAERS Report – Flu Vaccination (09/16/2021, Resulting in Right Shoulder Pain)
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FDA Summary Basis of Approval – Labeling Information for Glatiramer Acetate Injection, 40 mg/mL (Application A206873, Approved September 25, 2024)
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FDA Summary Basis of Approval – CMC Section for Eribulin Mesylate Injection 1 mg/2 mL (Application A217250, Approved October 1, 2024)
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