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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Approval Letter – ANDA 215503 (Liraglutide, Approved Dec 23, 2024)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Annora Pharma Private Limited (Inspection on 2023‑01‑24, FEI 3013944676)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Exela Pharma Sciences, LLC (Lenoir, NC, Inspection Ending Nov 15, 2024, FEI 3008563008)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Torbay Pharmaceuticals Ltd. (Paignton, UK, Inspection Ending Nov 12, 2024, FEI 3016482316)
Regular price $69.00 USDRegular priceUnit price / per -
Packaging Insert & Labeling – Phytonadione Injection (1mg/0.5 mL, ANDA 214966, CIPLA LTD)
Regular price $69.00 USDRegular priceUnit price / per -
Labels – NDA 017422 BICNU (Carmustine 100mg/vial, All Levels for RLD Comparison)
Regular price $69.00 USDRegular priceUnit price / per -
Labels – BLA 020563 HUMALOG (Insulin Lispro Recombinant, All Strengths/Levels)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Novo Nordisk A/S Inspection (Brennnum Park 25A, Hillerød, Denmark, 01/17/2020, FEI 3003131673)
Regular price $69.00 USDRegular priceUnit price / per -
Approval Letter – Prucalopride Succinate Tablets (EQ 1mg & 2mg, ANDA 218492, NOVITIUM PHARMA LLC)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Boiron Inc. Inspection (Newton Square, PA, 09/11/2023, Drug Quality Assurance)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Nov 2024: Bausch Health US., LLC; Dexcom, Inc.; Boston Scientific Corporation
Regular price $69.00 USDRegular priceUnit price / per -
Labeling Request – NDA 016087 VALIUM (Diazepam, Roche)
Regular price $69.00 USDRegular priceUnit price / per -
Tentative Approval Letter – Estradiol Valerate & Dienogest (ANDA 202349, Watson Labs Inc)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Ridgecrest Herbals, Inc. Inspection (Salt Lake City, USA, 11/17/2016, FEI 1000517647)
Regular price $69.00 USDRegular priceUnit price / per -
Redacted Form 483 & Response – Mylan Laboratories Limited, Inc. (Indore, India, 06/14–26, 2024, FEI 3010453141)
Regular price $69.00 USDRegular priceUnit price / per -
Inspection Reports – ProFresh International Corp. (Philadelphia, PA, 07/16/2021, FEI 3003273521); BioDelivery Sciences International, Inc. (Raleigh, NC, 05/21/2021, FEI 3013975812)
Regular price $69.00 USDRegular priceUnit price / per -
Inspection Reports – Specialty Process Labs (Phoenix, AZ, 11/04/2021, FEI 3017888878); WCCT Global, Inc. (Cypress, CA, 06/18/2021, FEI 3006237846); Qikmoov LLC (Norwalk, CA, 06/30/2021, FEI 3017721316)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Hubei Gedian Humanwell Pharmaceutical Co., Ltd. (FEI 3004117486; Inspections IDs 854699, 971471, 1098272)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Harman Finochem Limited (Aurangabad, India, 03/22/2024, FEI 3003130103)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Charles River Laboratories Inc. (Horsham, USA, 03/15/2024, FEI 2522835)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483s – Astellas Pharma US Inc. (Northbrook, IL, 08/14/2023, FEI 1000036852) & Sweet’s Elderberry LLC (Charlotte, NC, 08/22/2024, FEI 3017679537)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Mylan Laboratories Limited Inspection (Indore SEZ Pharma Zone, India, Jun 14–26, 2024, FEI 3010453141)
Regular price $69.00 USDRegular priceUnit price / per -
Clinical Pharmacology & Biopharmaceutics Review – Inderal (Propranolol Tablets, Wyeth, N016418)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Lions Eye Bank For Long Island (Valley Stream, NY, 08/03/2023, FEI 3001518813)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Micro‑Macinazione SA Inspection (Monteggio, Switzerland, 05/31/2019, FEI 3002807618)
Regular price $69.00 USDRegular priceUnit price / per -
Labels – BLA 103353 Neupogen (filgrastim 300 mcg & 480 mcg, All Strengths/Concentrations)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Acella Pharmaceuticals, LLC Inspection (Alpharetta, GA, 12/18/2024, FEI 3006691461)
Regular price $69.00 USDRegular priceUnit price / per -
Last Approved Labeling – NDA 019443 (Sodium Bicarbonate in Plastic Container, Abbott)
Regular price $69.00 USDRegular priceUnit price / per -
EIR Reports – South Texas Blood & Tissue Center and Fixed Donation Sites (FEI 3005772437, 3005942756, 3006805684, 3007003817, 3012347495; Jun 2022–May 2024)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 3542 Forms – NDA N212690 (XYWAV, Patents > $12M)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Communications – Belcher Pharmaceuticals, LLC (483s, EIRs, Response Letters, etc.)
Regular price $69.00 USDRegular priceUnit price / per -
CBER Director Response – Bluebird Bio Dispute (Lyfgenia, BLA #125788)
Regular price $69.00 USDRegular priceUnit price / per -
Approval Documents – Lumryz (NDA #214755, Approval Letter, Labeling, REMS, Review Files, Sponsor Communications)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483s – Fitbit Inc. (San Francisco, 5/22/2023, FEI 3009253624) & Elementis SRL, Inc. (Huguenot, NY)
Regular price $69.00 USDRegular priceUnit price / per -
EIR – Baxter Haina Facility (EXT‑2018‑0127, May 28–31, 2018, Lead Inspector Sonya Karsik)
Regular price $69.00 USDRegular priceUnit price / per -
Empower Clinic Services – Warning Letter Response & FDA 483 (Empower Pharmacy, Oct 15, 2021 & Mar 06/27, 2020)
Regular price $69.00 USDRegular priceUnit price / per