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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FDA Clinical Trial Data & Study Reports – Post-Marketing Evaluations & Approved Advertising from NDAs (4 Items)
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FDA Communications – Sponsor-FDA Discussions on Gepirone (Exxua, NDA 021164) Marketing Status
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FDA Medical, Chemistry & Clinical Pharmacology Reviews – RLD/RS Trimethoprim Tablets 100 mg, Application N018679 (Dr Reddy’s Laboratories SA)
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FDA Medical, Chemistry & Clinical Pharmacology Reviews – RLD Biltricide® (Praziquantel) Tablets 600 mg, Application N018714 (Bayer Healthcare)
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FDA FAERS Database – Neffy (Epinephrine Nasal Spray, 2 mg/spray, NDA 214697) (1/1/2024–Present)
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FDA Approval Package – NDA 020392 for CYSTAGON Capsules (50 mg & 150 mg, Mylan Pharmaceuticals Inc.)
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FDA Complete Labeling Components – Decadron (Dexamethasone Sodium Phosphate Solution/Drops EQ 0.1%, NDA 011984)
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FDA Carton & Container Label – RLD (N208574)
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FDA Pharmacology & Toxicology Review – BLOCADREN (Timolol Maleate), NDA #018017
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FDA FAERS Database – Neffy (Epinephrine Nasal Spray, 2 mg/spray, NDA 214697) (January 2024–Present)
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FDA Summary Basis of Approval – SOLU‑MEDROL NDA N011856 & SOLU‑CORTEF NDA N009866
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FDA Product Quality, Chemistry & Biopharmaceutics Review – NDA #N011459 (Vistaril Capsule)
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FDA Ingredient Component Table for Gynorest NDA 17388 (circa October 31, 1978)
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FDA Summary Basis of Approval for GLYDO Jelly 2% (NDA A201094) – Sagent Pharmaceuticals Inc.
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FDA Black Box Warning Documentation – Earliest Issuance for Citalopram (Celexa)
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FDA Bills of Lading – Hubei JXBio Pharmaceutical Co. (FEI 3016784508)
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FDA Liaison Meeting Summary – Microbiome Therapeutics Innovation Group with CBER (09/19/2024)
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FDA GRN 1117 Information – Neurospora crassa Mycelial Biomass & Correspondence
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FDA Annual CBER New Product Approval Reports (1982–1994)
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FDA Inspection Documentation – Pine Pharmaceuticals, LLC (2024)
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FDA Correspondence Records – FDA & Bestzyme/CIRS Group on Brazzein
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FDA Chemical Sourcing & Administration for Lethal Injection (Including Absolute Standards)
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FDA Medical Review – ENHERTU SUPPL‑28 for Adult HER2‑Positive Solid Tumors (Approved April 5, 2024)
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FDA Immunotherapy Side Effects Database – Oncology Research Access
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FDA Clinical Studies & Trials – In-Depth Analysis of ADHD Medication (Branded & Generic; FDA Trial Phases)
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FDA Approval Letter & Product Label – PROMACTA (Eltrombopag Olamine) for Litigation in India (Certified Copies)
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FDA Durvalumab Records – Variables (Age, Gender, Weight, Race, Outcomes, etc.) (2024)
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FDA Dolobid 250 mg Application Transfer Records – ANDA #202845 (Ownership, Correspondence, and Acknowledgement Letters)
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FDA Orange Book Data Files – Annual Edition 33 (Dec 2013): product.txt, patent.txt, exclusivity.txt
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FDA Public Comment – Hims & Hers Health, Inc. on Compounding of Human Drug Products (Dkt. No. FDA‑2015‑N‑0030; Filed 11/15/2024)
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FDA Complete File for P150017 S012 (2023–2024)
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FDA Complete File for P150017 S011 (2023–2024)
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FDA Imperial Trial 36-Month Results & Data Inquiry – Boston Scientific (2022–2024)
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FDA Documentation on Hypercare Antiperspirant Distribution Cessation – Sonar Products Inc./Stratus Pharmaceuticals (2022–2024)
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FDA Submission Materials for Filshie Clip (Mark VI) System – P920046/S012 (Femcare Ltd. & FDA Decision)
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FDA records on Coronavirus Studies & Executive Order (2020–2024)
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