FDA letter monthly archive

FDA Letters Issued in January 2025

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

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

CRLComplete Response Letter
Complete Response Letter SFJ Pharmaceuticals, Inc. (Jan 31, 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.
IssuedJan 31, 2025
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Hospira, Inc. (Jan 17, 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.
IssuedJan 17, 2025
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Atara Biotherapeutics, Inc. (Jan 15, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJan 15, 2025
US FDA• tabelecleucel
CRLComplete Response Letter
Complete Response Letter OWP Pharmaceuticals, Inc. (Jan 3, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJan 3, 2025
US FDA• SUBVENITE
CRLComplete Response Letter
Complete Response Letter Tanvex BioPharma USA, Inc. (Jan 3, 2025)
FDA's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJan 3, 2025
US FDA• Unknown

Complete Response Letter SFJ Pharmaceuticals, Inc. (Jan 31, 2025)

Complete Response Letter Hospira, Inc. (Jan 17, 2025)

Complete Response Letter Atara Biotherapeutics, Inc. (Jan 15, 2025)

Complete Response Letter OWP Pharmaceuticals, Inc. (Jan 3, 2025)

Complete Response Letter Tanvex BioPharma USA, Inc. (Jan 3, 2025)