FDA LETTER LIBRARY

FDA application & warning letters

Name: FDA Approval, Complete Response & Warning Letters
Creator: Assyro AI
License: https://www.usa.gov/government-works

Review 1,503 source-backed approval, tentative approval, complete response, and warning letters. Application letters cover 2026; the CRL corpus is complete as published by openFDA, and warning letters cover 2026.

Showing 25-36 of 1503 letters

CRLComplete Response Letter
Complete Response Letter Chiesi Farmaceutici S.p.A (Feb 27, 2026)
FDA issued a complete response letter. No controlled deficiency theme met the deterministic text-matching threshold; review the exact redacted letter.
IssuedFeb 27, 2026
US FDA• FDA-regulated product
CRLComplete Response Letter
Complete Response Letter Fresenius Kabi USA, LLC (Feb 27, 2026)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedFeb 27, 2026
US FDA• NDA 215818
CRLComplete Response Letter
Complete Response Letter Amphastar Pharmaceuticals, Inc. (Feb 26, 2026)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedFeb 26, 2026
US FDA• BLA 761403
CRLComplete Response Letter
Complete Response Letter Disc Medicine, Inc. (Feb 13, 2026)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedFeb 13, 2026
US FDA• NDA 220707
CRLComplete Response Letter
Complete Response Letter REGENXBIO, Inc. (Feb 7, 2026)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Safety and adverse events, Labeling, packaging, and proprietary name, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedFeb 7, 2026
US FDA• FDA-regulated product
CRLComplete Response Letter
Complete Response Letter Aquestive Therapeutics Inc. (Jan 30, 2026)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Device constituent and human factors, Safety and adverse events, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJan 30, 2026
US FDA• NDA 219870
CRLComplete Response Letter
Complete Response Letter Corcept Therapeutics (Jan 28, 2026)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJan 28, 2026
US FDA• NDA 219398
CRLComplete Response Letter
Complete Response Letter Pierre Fabre Pharmaceuticals Inc. (Jan 9, 2026)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Safety and adverse events, Chemistry, manufacturing, and controls, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJan 9, 2026
US FDA• FDA-regulated product
CRLComplete Response Letter
Complete Response Letter Dr. Reddy’s Laboratories, Inc. (Dec 30, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 30, 2025
US FDA• BLA 761471
CRLComplete Response Letter
Complete Response Letter Outlook Therapeutics, Inc. (Dec 30, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 30, 2025
US FDA• LYTENAVA
CRLComplete Response Letter
Complete Response Letter Genzyme Corporation (Dec 23, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Statistical analysis, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 23, 2025
US FDA• NDA 219624
CRLComplete Response Letter
Complete Response Letter MedicaSafe, Inc. (Dec 22, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, Clinical efficacy and substantial evidence, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 22, 2025
US FDA• NDA 220184

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Complete Response Letter Chiesi Farmaceutici S.p.A (Feb 27, 2026)

Complete Response Letter Fresenius Kabi USA, LLC (Feb 27, 2026)

Complete Response Letter Amphastar Pharmaceuticals, Inc. (Feb 26, 2026)

Complete Response Letter Disc Medicine, Inc. (Feb 13, 2026)

Complete Response Letter REGENXBIO, Inc. (Feb 7, 2026)

Complete Response Letter Aquestive Therapeutics Inc. (Jan 30, 2026)

Complete Response Letter Corcept Therapeutics (Jan 28, 2026)

Complete Response Letter Pierre Fabre Pharmaceuticals Inc. (Jan 9, 2026)

Complete Response Letter Dr. Reddy’s Laboratories, Inc. (Dec 30, 2025)

Complete Response Letter Outlook Therapeutics, Inc. (Dec 30, 2025)

Complete Response Letter Genzyme Corporation (Dec 23, 2025)

Complete Response Letter MedicaSafe, Inc. (Dec 22, 2025)