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 1-12 of 1503 letters

CRLComplete Response Letter
Complete Response Letter Apiject Systems Corp. (Jul 21, 2026)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJul 21, 2026
US FDA• NDA 219107
CRLComplete Response Letter
Complete Response Letter Elevar Therapeutics Inc. (Jul 9, 2026)
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 9, 2026
US FDA• NDA 216586
CRLComplete Response Letter
Complete Response Letter Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jul 9, 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. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJul 9, 2026
US FDA• BLA 761308
CRLComplete Response Letter
Complete Response Letter Ascelia Pharma AB (Jul 2, 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.
IssuedJul 2, 2026
US FDA• NDA 220544
CRLComplete Response Letter
Complete Response Letter Ipsen Biopharm Ltd. (Jun 29, 2026)
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 29, 2026
US FDA• BLA 761311
CRLComplete Response Letter
Complete Response Letter Unicycive Therapeutics Inc. (Jun 29, 2026)
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 29, 2026
US FDA• NDA 218607
CRLComplete Response Letter
Complete Response Letter Evergreen Theragnostics, Inc. (Jun 26, 2026)
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 26, 2026
US FDA• NDA 216900
CRLComplete Response Letter
Complete Response Letter Swedish Orphan Biovitrum AB (publ) (Jun 26, 2026)
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 26, 2026
US FDA• BLA 761438
CRLComplete Response Letter
Complete Response Letter Tanvex BioPharma USA, Inc. (Jun 23, 2026)
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 23, 2026
US FDA• BLA 761266
CRLComplete Response Letter
Complete Response Letter Achieve Life Sciences, Inc. (Jun 20, 2026)
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 20, 2026
US FDA• NDA 218995
CRLComplete Response Letter
Complete Response Letter Tris Pharma, Inc. (Jun 15, 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, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 15, 2026
US FDA• NDA 220138
CRLComplete Response Letter
Complete Response Letter Bridge Regulatory Affairs, LLC (Jun 10, 2026)
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 10, 2026
US FDA• NDA 218600

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Complete Response Letter Apiject Systems Corp. (Jul 21, 2026)

Complete Response Letter Elevar Therapeutics Inc. (Jul 9, 2026)

Complete Response Letter Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jul 9, 2026)

Complete Response Letter Ascelia Pharma AB (Jul 2, 2026)

Complete Response Letter Ipsen Biopharm Ltd. (Jun 29, 2026)

Complete Response Letter Unicycive Therapeutics Inc. (Jun 29, 2026)

Complete Response Letter Evergreen Theragnostics, Inc. (Jun 26, 2026)

Complete Response Letter Swedish Orphan Biovitrum AB (publ) (Jun 26, 2026)

Complete Response Letter Tanvex BioPharma USA, Inc. (Jun 23, 2026)

Complete Response Letter Achieve Life Sciences, Inc. (Jun 20, 2026)

Complete Response Letter Tris Pharma, Inc. (Jun 15, 2026)

Complete Response Letter Bridge Regulatory Affairs, LLC (Jun 10, 2026)