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 1,819 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 61-72 of 1819 letters

CRLComplete Response Letter
Complete Response Letter Accord BioPharma, Inc. (Aug 5, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 5, 2025
US FDA• ENNUMO
CRLComplete Response Letter
Complete Response Letter Conjupro Biotherapeutics Inc. (Jul 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.
IssuedJul 30, 2025
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Teva Pharmaceuticals, Inc. (Jul 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.
IssuedJul 30, 2025
US FDA• PONLIMSI
CRLComplete Response Letter
Complete Response Letter Regeneron Pharmaceuticals, Inc. (Jul 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.
IssuedJul 30, 2025
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc. (Jul 28, 2025)
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.
IssuedJul 28, 2025
US FDA• ATAZANAVIR SULFATE; RITONAVIR
CRLComplete Response Letter
Complete Response Letter Replimune, Inc. (Jul 21, 2025)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJul 21, 2025
US FDA• vusolimogene oderparepvec
CRLComplete Response Letter
Complete Response Letter Capricor, Inc. (Jul 9, 2025)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Statistical analysis, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJul 9, 2025
US FDA• deramiocel
CRLComplete Response Letter
Complete Response Letter Ultragenyx Pharmaceutical Inc. (Jul 7, 2025)
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJul 7, 2025
US FDA• rebisufligene etisparvovec
CRLComplete Response Letter
Complete Response Letter Unicycive Therapeutics Inc. (Jun 27, 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.
IssuedJun 27, 2025
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Accord BioPharma Inc. (Jun 26, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 26, 2025
US FDA• FILKRI
CRLComplete Response Letter
Complete Response Letter Sun Pharmaceutical Industries Limited (Jun 25, 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.
IssuedJun 25, 2025
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Cipla USA, Inc. (Jun 20, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 20, 2025
US FDA• Unknown

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Complete Response Letter Accord BioPharma, Inc. (Aug 5, 2025)

Complete Response Letter Conjupro Biotherapeutics Inc. (Jul 30, 2025)

Complete Response Letter Teva Pharmaceuticals, Inc. (Jul 30, 2025)

Complete Response Letter Regeneron Pharmaceuticals, Inc. (Jul 30, 2025)

Complete Response Letter Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc. (Jul 28, 2025)

Complete Response Letter Replimune, Inc. (Jul 21, 2025)

Complete Response Letter Capricor, Inc. (Jul 9, 2025)

Complete Response Letter Ultragenyx Pharmaceutical Inc. (Jul 7, 2025)

Complete Response Letter Unicycive Therapeutics Inc. (Jun 27, 2025)

Complete Response Letter Accord BioPharma Inc. (Jun 26, 2025)

Complete Response Letter Sun Pharmaceutical Industries Limited (Jun 25, 2025)

Complete Response Letter Cipla USA, Inc. (Jun 20, 2025)