FDA letter monthly archive

FDA Letters Issued in April 2025

Name: FDA Letters Issued in April 2025
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in April 2025. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Fresenius Kabi USA, LLC (Apr 25, 2025)
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.
IssuedApr 25, 2025
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Telix Pharmaceuticals (US) Inc. (Apr 25, 2025)
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.
IssuedApr 25, 2025
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter University of California San Francisco (Apr 25, 2025)
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.
IssuedApr 25, 2025
US FDA• floretyrosine F 18
CRLComplete Response Letter
Complete Response Letter Amneal EU, Limited (Apr 2, 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.
IssuedApr 2, 2025
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Aldeyra Therapeutics, Inc. (Apr 2, 2025)
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.
IssuedApr 2, 2025
US FDA• Unknown

Complete Response Letter Fresenius Kabi USA, LLC (Apr 25, 2025)

Complete Response Letter Telix Pharmaceuticals (US) Inc. (Apr 25, 2025)

Complete Response Letter University of California San Francisco (Apr 25, 2025)

Complete Response Letter Amneal EU, Limited (Apr 2, 2025)

Complete Response Letter Aldeyra Therapeutics, Inc. (Apr 2, 2025)