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.
Use Search 
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.
-
FDA Summary Basis of Approval – Naltrexone Hydrochloride (Revia) Tablet 50 mg for TEVA WOMENS HEALTH INC, NDA N018932
Regular price $69.00 USDRegular priceUnit price / per -
FDA CLOZAPINEREMS.COM – REMS Program Org Chart & Financials (09/01/2015–10/22/2015)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Records – Pine Pharmaceuticals (Tonawanda, NY, FEI 3010943533): Inspections, Recalls & Correspondence
Regular price $69.00 USDRegular priceUnit price / per -
FDA Feed Testing & Recall Documents – Valley View Milling, LLC (Including “14% Allstock Feed,” Stop Sale Orders, Complaints from 2023–Present)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Inspection, Recall & Warning Letter Records – Totally Cool Inc (FEI 3003620544, Owings Mills, MD)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Correspondence – Dollar Tree/Family Dollar/Ecuador’s ARCSA Regarding Wanabana USA Recall (Terminated 3/4/2024)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Grimmway Farms – Establishment Inspection Reports, 483 Forms, Warning Letters & Voluntary Recall Documents (2020–Present; Recall Initiated 11/16/2024)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Investigation Outcomes & Documentation for Terminated Prismaflex Recalls (2023–2024)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Recall Reports for Cubicin 500 mg IV – RES #88867/D-0093-2022
Regular price $69.00 USDRegular priceUnit price / per -
FDA Recall Reports for Topotecan Injection – RES #88154/D-0661-2021 (Recall Details)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Recalls, Warnings & Communications for GL 7021 Mogen Clamp (2019–2024)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Thomas Danisi FOIA Requests & Responses
Regular price $69.00 USDRegular priceUnit price / per -
FDA FOIA Log – For Specified Dates
Regular price $69.00 USDRegular priceUnit price / per -
FDA FOIA Denials Log – 7(a) Exemption (November 2024, Including Date, Requester Name, Request Text, Agency Response)
Regular price $69.00 USDRegular priceUnit price / per -
FDA FOIA Case Files Sample – Up to 10 Completed Cases (06/01/2023–01/01/2024, Including Agency Response, Requester Clarification, Final Determination Letter)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Guayakí Yerba Mate – Co-Manufacturing Facilities & Associated Inspection/Registration Records (2024)
Regular price $69.00 USDRegular priceUnit price / per -
FDA FOIA Request on Form 3500 – Report Nos: 1030489-2021-01021, 1030489-2017-01884, 1030489-2014-04500, 1030489-2014-03707, 1030489-2014-02296, 1030489-2013-03014
Regular price $69.00 USDRegular priceUnit price / per -
FDA Internal Denial Memorandum – FOIA Request 2022-4855
Regular price $69.00 USDRegular priceUnit price / per -
FDA Last Approved Labeling – Discontinued RLD OPHTHAINE 0.5% (NDA 008883)
Regular price $69.00 USDRegular priceUnit price / per -
FDA CDER Exclusivity Board Memo – 3-Year Exclusivity for Jatenzo (NDA 206089)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Unredacted Application Review Files – Sun’s LEQSELVI 8MG Tablets (App 217900)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Annual Reports – New Drug Therapy Approvals (First‑in‑Class, Orphan, Fast Track, Breakthrough, Priority Review, etc.)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Accelerated Approval Program – Applications, Approvals & Denials (2014–Present)
Regular price $69.00 USDRegular priceUnit price / per -
FDA NDA 019523 Labeling – Primary Container Additive Syringe Label & Package Insert for 7.25% Cysteine Hydrochloride Injection (Hospira Inc.)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Summary Basis of Approval – NDA 012575 ACTIFED with Codeine
Regular price $69.00 USDRegular priceUnit price / per -
FDA NDA Approval Package – THIOLA (Tiopronin) Tablet 100 mg (NDA 019569, Azurity Pharmaceuticals, Inc.)
Regular price $69.00 USDRegular priceUnit price / per -
FDA NDA Documentation – Depot Medroxyprogesterone Acetate (Depo‑Provera® and Depo‑SubQ Provera®)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Packaging Insert & Labeling – Hydrocortisone Sodium Phosphate (RTU) Injection 50 MG BASE/ML (Discontinued; NDA 012052, MERCK AND CO INC)
Regular price $69.00 USDRegular priceUnit price / per -
FDA SBOA – Hydrocortisone Sodium Phosphate (RTU) Injection 50 MG BASE/ML (Discontinued; NDA 012052, MERCK AND CO INC)
Regular price $69.00 USDRegular priceUnit price / per -
FDA RLD/RS Review Reports – Ibuprofen Capsules, 200 mg (NDA 020402, HALEON US HOLDINGS)
Regular price $69.00 USDRegular priceUnit price / per -
FDA NDA N018654 Labels – VERSED (EQ 5MG BASE/ML) by ITAAN PHARMA INC (Including Prescribing Information, Package Insert, Carton & Container Labels)
Regular price $69.00 USDRegular priceUnit price / per -
FDA SBOA – Hydrocortisone Sodium Succinate for Injection, NDA 009866 (Applicant: PHARMACIA AND UPJOHN)
Regular price $69.00 USDRegular priceUnit price / per -
FDA RLD INFeD® – Product Quality/Chemistry Review for Iron Dextran Injection, NDA 017441 (ALLERGAN)
Regular price $69.00 USDRegular priceUnit price / per -
FDA RLD INFeD® – Clinical Review for Iron Dextran Injection, NDA 017441 (ALLERGAN)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Approved Labels – NDA 080556, Thiamine Hydrochloride in SUPPL-38 for RLD Meitheals (Action Date 11/14/2024)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Review Documents – Second-Generation Diazepam Rectal Gel (DIASTAT ACUDIAL 20MG/4ML & 10mg/2ML, NDA 020648)
Regular price $69.00 USDRegular priceUnit price / per