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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483 Report – Haupt Pharma Latina S.r.l. Animal Health Inspection (Italy, 2/21/2024)
Regular price $69.00 USDRegular priceUnit price / per -
Veterinary Medicine Organizational Charts – FDA Center for Veterinary Medicine
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – Nanjing White Whale Pharmaceutical Co. Animal Health Inspection (1/25/2024)
Regular price $69.00 USDRegular priceUnit price / per -
NADA Request – Original NADA 113-645 for Cloprostenol (Estrumate)
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – Biocon Biologics Limited Animal Health Inspection (Bengaluru, India, 2/28/2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Reports – Animal Health Inspections: Rancher's US OP LLC & Talley Farms Feed Mill Inc.
Regular price $69.00 USDRegular priceUnit price / per -
CTP Organizational Charts – FDA Center for Tobacco Products
Regular price $69.00 USDRegular priceUnit price / per -
PMTA Submission – Lust Vapes LLC (Reg RG8850, Multiple STNs)
Regular price $69.00 USDRegular priceUnit price / per -
CTP PMTA Reviewer Guides – Oral Nicotine Pouches (Since 1/1/2023)
Regular price $69.00 USDRegular priceUnit price / per -
Email Communications (May–Oct 2023) – Brian King & Colleagues on Tobacco Products
Regular price $69.00 USDRegular priceUnit price / per -
PMTA Social Science Review Memo (June 25, 2020) – VERVE® Discs & Chews (Blue & Green Mint)
Regular price $69.00 USDRegular priceUnit price / per -
CTP Disclosures – Reviewer Summaries & Guides for STN EX0002449
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Novartis Pharmaceuticals Corporation Inspection (NJ District Office, 08/08/2023, Drug Quality Assurance)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Siegfried Evionnaz SA Inspection (Evionnaz, Switzerland, 03/31/2023, FEI 3002807824, Human Drugs)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Penta International Corp Inspection (West Caldwell, NJ, FEI 2246566, Inspection ID 1231026)
Regular price $69.00 USDRegular priceUnit price / per -
Summary Basis of Approval Request – ANDAs 218366 (Carnegie Pharmaceuticals) & 214896 (Rubicon Research Private Ltd.)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Church & Dwight Co., Inc. Inspection (Lakewood, USA, 10/25/2024, FEI 2224549, Human Drugs)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Jiangsu Anbison Pharmaceutical Co., Ltd. (Taizhou, China, FEI 3021121841, Inspections Jul 2024 & Aug 2023)
Regular price $69.00 USDRegular priceUnit price / per -
NDA 021924 Request – TIROSINT (Levothyroxine Sodium, Chemistry & Bioequivalence Reviews)
Regular price $69.00 USDRegular priceUnit price / per -
Summary Basis of Information – NDA #011795 (Comprehensive Review Documents)
Regular price $69.00 USDRegular priceUnit price / per -
Summary Basis of Information – NDA #011459 (Comprehensive Review Documents)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Advanced Nutriceuticals, LLC Inspection (Indianapolis, IN, 11/22/2024, FEI 3010039017)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – WuXi Biologics Co., Ltd. (FEI 3010606982, Inspection 04/24/2023–05/09/2023)
Regular price $69.00 USDRegular priceUnit price / per -
EIR – Neuland Laboratories Limited Inspection (Pashamylaram, Hyderabad, India, FEI 3003309323, Unit II)
Regular price $69.00 USDRegular priceUnit price / per -
Quality Discipline Review – Octreotide Acetate Injectable (ANDA‑210317, TEVA PHARMS USA INC)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Safetec of America Inc. Inspection (Buffalo, NY, 11/15/2024, FEI 1000159898)
Regular price $69.00 USDRegular priceUnit price / per -
EIR & 483 – Genzyme Corporation (Sanofi Subsidiary, New York Avenue Campus, 09-Jun–12-Jul 2024, Ref. Warning Letter 320‑25‑22)
Regular price $69.00 USDRegular priceUnit price / per -
Label Information Request – ANDA#210354
Regular price $69.00 USDRegular priceUnit price / per -
Summary Basis of Approval – NDA019185 (Abbott Laboratories, Final Labeling, Requested by B. Braun)
Regular price $69.00 USDRegular priceUnit price / per -
Packaging Insert & Labeling Request – Octreotide Acetate Injectable (ANDA‑210317, TEVA PHARMS USA INC)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Integra LifeSciences Corporation Inspection (Mansfield, USA, 06/05/2024, FEI 3014334038)
Regular price $69.00 USDRegular priceUnit price / per -
Inspection Reports – Kovas Co., Ltd (Paju, Korea, FEI 3009640188; Inspections Nov 18–22, 2019 & Nov 25–29, 2024)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Empower Clinic Services New Jersey, LLC Inspection (East Windsor, NJ, 11/18/2024, FEI 3033132864)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Inova Health Care Services Biologics Inspection (Sterling, VA, 08/07/2019, FEI 1177788)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Cilag AG Inspection (Schaffhausen, Switzerland, 09/23/2024, FEI 3002806695)
Regular price $69.00 USDRegular priceUnit price / per -
Inspection Reports & Warning Letter – Genzyme Corporation (Framingham, MA; Inspection IDs 1176107 & 1232210; Warning Letter Case ID 690604)
Regular price $69.00 USDRegular priceUnit price / per