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.Can't find what you are looking for? Submit a Custom Request.
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FDA Toxicity Study Reports on Fucoxanthin (NDIN 1048)
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FDA Contract Number 75F40121A00003 Document Request
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FDA 483 for Hubei JXBio Pharmaceutical Co., China, Animal Health Inspection Ending 08/30/2024
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FDA 483s for Commercial Plastics LLC and Veridiam Inc., Inspections Ending 11/07/2024 and Others
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FDA 483 for Philips Medizin Systeme Böblingen GmbH, Germany, Inspection Ending 03/07/2024
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FDA Inspection Records and Recalls Related to Ferrara Candy Company
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FDA Pre/Post-Submission Communications on Monellin or Serendipity Berry
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FDA Pre/Post-Submission Communications on Brazzein or Oubli Sweet Protein
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FDA Decision Memo and Letters for 510(k) K173352
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FDA Inspection and Correspondence Records for Ungerer & Company, Bethlehem PA
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FDA Records for Melatonin Supplement Study by FDA Regulatory Science Staff
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FDA Approval Files for Elrexfio, Vonjo, Galafold, Tafinlar
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FDA 510(k) Summary Request for K241361
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FDA 483 for Marini y Compania, Argentina, Animal Health Inspection Ending 01/18/2024
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FDA ANDA 213191 Approval Package for Mesalamine 800 mg DR Tablets – Approved 08/22/2024
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FDA 483 for Implants International Ltd., UK, Inspection Ending 07/25/2024
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FDA 510(k) K240782 CellFX Percutaneous Electrode System Full Submission
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FDA Correspondence Re: Taylor Farms with McDonald's, Yum! Brands, and Others (2021–2024)
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FDA 483 for Serumwerk Bernburg AG, Germany, Animal Health Inspection Ending 06/14/2024
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FDA 483 for Immunotech SAS, France, Inspection Ending 03/14/2024
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FDA Latest Approved ANDA 089839 (Quinidine Sulfate) Pack Insert as of 06/10/1996 SUPPL-6
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FDA 483s for Sanitation & Environmental Tech Institute and BroadMaster Biotech – 2024 Inspections
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FDA Updated Complaints Related to Hims Products and Compounding Pharmacies
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FDA CARA Evaluation Records for E. coli Investigation Ref #1215
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FDA Records on Nara Organics, Inc – Infant Formula Notifications
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FDA NDA 216483 Review Package for Pivya (pivmecillinam hydrochloride)
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FDA 483 for Sanitation & Environmental Tech Institute, China, Inspection Ending 03/15/2024
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FDA Summary Review Files for NDA 019430 (Epipen) and NDA 214697 (Neffy)
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FDA Training Materials and SOPs for Talc-Based Product Testing – Dynarex Case
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FDA Testing Protocols and Reports for Dynacare Baby Powder – Asbestos Testing
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FDA Dynarex Baby Powder Testing and Recall – Correspondence and Meeting Records
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FDA 483 for Sanitation & Environmental Tech Institute, Suzhou, China, Inspection Ending 03/15/2024
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FDA 510(k) K221249 Submission for LIP-1F (TRIOS 5) by 3Shape
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FDA Records Related to Pharmaceutical Drug Syfovre
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FDA 483 for Sanofi S.r.l., Italy, Inspection Ending 02/02/2023
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FDA CVM-Zoetis Meeting Materials 09/18/2024 on Veterinary Issues
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