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 EMAILS TO/FROM DR. JANET WOODCOCK OR DR. PETER MARKS MENTIONING PROJECT VERITAS OR CHRISTOPHER COLE
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FDA CTP EMAILS RE: PUFF BAR & E-CIGARETTES INCLUDING MITCH ZELLER AND MICHELE MITAL
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FDA PHARMACOVIGILANCE RELATED TO COVID VACCINE
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FDA RANITIDINE SAMPLES TESTING AND MANUFACTURER COMMUNICATIONS REGARDING NDMA
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FDA WHISTLEBLOWER COMPLAINTS ON MYLAN MANUFACTURING FACILITIES 2015 AND 2018
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FDA PUBLIC COMPLAINTS ABOUT PUFF BAR 01/01/2020 - 07/15/2020
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FDA ALL ENFORCEMENT LETTERS AND INVESTIGATIONS FOR ALLOGRAFT GRAFTLINK CONSTRUCT BY ARTHREX AND LIFENET HEALTH
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FDA BRIEFING MATERIALS ON STATE-LEVEL PHARMA IMPORTATION PLANS
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FDA 23ANDME AUTHORIZATION TO MARKET DIRECT-TO-CONSUMER GENETIC TESTS 2013 TO PRESENT
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FDA NDMA IN RANITIDINE FINDINGS AND SAMPLING RESULTS 06/01/2019 - 10/03/2019
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FDA RECS RE SPRAVADO
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FDA COMMUNICATIONS BETWEEN FDA AND MYLAN, FDA AND HEALTH CANADA RE EPIPEN SHORTAGE 01/01/2018 - 05/16/2018
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FDA LANTUS CORR WITH MANUFACTURER, CORR WITH VA, DATA
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FDA MITRE CORP - AWARD HHSSF22320160236W
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FDA AMICUS THERAPEUTICS MIGALSTAT HCI - COMMUNICATIONS ETC 01/01/2009 - 07/19/2017
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FDA ASBESTOS IN TALC - RPTS
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FDA Latest Container Label – TARGRETIN (NDA #021055)
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FDA MedWatch Forms and Narratives – Multiple FAERS Cases
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FDA FSVP Importer Listings – P&D FDA Consulting LLC (Nov 2023–Nov 2024)
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FDA Drug Approval Package – Fluvoxamine Maleate ER Capsules (ANDA #091482)
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FDA Superseding Exclusivity Summary – Tyvaso DPI (NDA 214324)
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FDA FAERS Reports – Winrevair (Sotatercept) by Merck
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FDA FAERS Reports – Winrevair (Sotatercept) Oct 2024
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FDA FAERS Reports – IZERVAY (Oct 24–30, 2024)
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FDA FAERS Reports – SYFOVRE (Oct 24–30, 2024)
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FDA FOIA Request 2024-9249 – Form 483 for Regeneron (FEI 1000514603), Mar 2024
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FDA FOIA Request 2024-9248 – Form 483 for Novartis (FEI 3010353512), Aug 2024
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FDA FSVP Importer Listings – Coast to Coast Produce LLC (Mar–Nov 2024)
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FDA FAERS Reports – SYFOVRE (1/1/24 to 11/5/24)
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FDA FAERS Reports – Case IDs 24283702, 24180954, 24133076, 24067002
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FDA FAERS Reports – IZERVAY (1/1/24 to 11/5/24)
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FDA Approval Letter – A040834 Acetaminophen; Hydrocodone Bitartrate
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FDA MedWatch Reports – Human Drug Cases (Case IDs)
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FDA 510(k) Copy Request – K862198
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FDA 510(k) Copy Request – K990927
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FDA Inspection Report – Tortilleria La Perla, Jan 23, 2024
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