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 Criteria for New Food Labeling Requirements – Added sugars, bioengineered ingredients, and consumer transparency.
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FDA Establishment Inspection Reports (EIRs) for SciAnda Pharmaceuticals – Inspections in 2015 and 2024, FEI: 3009853264, Changshu, Jiangsu, China.
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FDA Form 483 for Bioiberica, SAU Facility – Palafolls, Spain (FEI 1000418405), Inspection ended 9/20/2024.
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FDA Safety Reports for Aprepitant – Case IDs: 24279279, 24205475, 24201898.
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FDA Case Reports for IDs: 22897455, 21268575, 232252581, 229699371, 223038123.
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FDA 483 Response for Patheon/Thermo Fisher Inspection – Related EIR and inspection classification letter, FEI: 1018495, Inspection: May 15-24, 2024.
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FDA Medical Review for Tafinlar + Mekinist Approval – Accelerated approval on June 22, 2022, NDA 202806/S-022.
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FDA De Novo Classification Request for Cognoa, Inc. – All documents related to Cognoa ASD Diagnosis Aid (DEN 200069).
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FDA Calendar Records for CVM Employee Charlotte Conway – From 03/01/2023 to 03/31/2023.
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FDA 510(k) K172431 Submission – Full file, including Master File, submissions, responses, and review memos.
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FDA 510(k) K110374 Submission – Full file, including Master File, submissions, responses, and review memos.
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FDA Viz.ai De Novo Application #DEN230003 – All related information from the interactive review process.
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FDA Establishment Inspection Report (EIR) for Bactolac Pharmaceutical, Inc. – Including any issued FDA Form 483 observations.
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FDA Review Reports for SEVENFACT BLA 125641/6 – Clinical and Statistical Reviewers' Reports, submitted by LFB on August 7, 2020.
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FDA Calendar Records for CVM Employee Isabel Pocurull – From 01/01/2021 to 01/31/2021.
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FDA Approved Package Insert for Gynorest (dydrogesterone tablets) – NDA 17388, approved October 31, 1978.
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FDA MDR Report Key 16592842 – All additional information for MDR Text Key 311785444, Report Number 2183553-2023-00001.
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FDA 510(k) K223144 Submission – Full application and pertinent data for Noah Medical Corp.’s Galaxy System.
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FDA Approval Summary for AFINITOR DISPERZ (NDA 203985/S-13) – Summary Review, Medical Review, and Nonclinical Pharmacology/Toxicology review from April 10, 2018.
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FDA Inspection Reports for Visco Technology SDN BHD and Visco Vision, Inc. – Inspections in Malaysia and Taiwan.
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FDA IDE K-036688 Submission – Full application and Instructions for Use for Sightline Technologies Ltd. colonoscopy system.
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FDA CDRH Intercenter Consult Memorandum – FUROSCIX NDA 209988, including Label, Labeling, and Human Factors Results Review.
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FDA PMA Supplement Application P160031/S004 – Received on November 15, 2022.
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FDA Emails from Emergency Operations – All emails (with attachments) sent to/from emergency.operations@fda.hhs.gov between February 1, 2022, and present.
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FDA Q-Submission Program Records – Requests for feedback and meetings for medical device submissions.
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FDA Documents on Apyx Medical Corporation – Communications on off-label uses of Renuvion, J-Plasma, and Advanced Energy Products.
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FDA Recall Number Z-0810-2021 – Information on specific pathogen(s), microbial species, or contaminant(s).
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FDA Establishment Inspection Report (EIR) for Kite Pharma, Inc. – Biologics inspection ending 03/04/2022 at Frederick, MD.
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FDA Memorandums from Dr. Janet Woodcock – All memos to FDA staffers and department heads.
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FDA Establishment Inspection Report (EIR) for Family Dollar Warehouse – Inspection ended February 11, 2022.
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FDA 510(k) Pre-Market Application K191402 – Includes all associated agency communications, Class 2 recall Z-1498-2020, and requests for additional information.
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FDA BK170108 Submission Documents.
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FDA BK130068 Submission Documents.
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FDA Certificates to Foreign Governments – U.S. firms from 01/01/2000 to 02/09/2018.
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FDA Records on LT CMDR COLBURN – Recommendations for service on outside boards of directors from 01/01/2012 to 07/22/2015.
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FDA 510(k), K072427, SIGMA SERIES HYPERBARIC CHAMBER
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