FDA letter monthly archive

FDA Letters Issued in May 2025

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

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

CRLComplete Response Letter
Complete Response Letter Chemo Research, S.L. (May 29, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMay 29, 2025
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Stealth BioTherapeutics Inc. (May 15, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, 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.
IssuedMay 15, 2025
US FDA• FORZINITY

Complete Response Letter Chemo Research, S.L. (May 29, 2025)

Complete Response Letter Stealth BioTherapeutics Inc. (May 15, 2025)