FDA letter monthly archive

FDA Letters Issued in April 2024

Name: FDA Letters Issued in April 2024
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in April 2024. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Dr. Reddy’s Laboratories SA (Apr 19, 2024)
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.
IssuedApr 19, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Xbrane Biopharma AB (Apr 19, 2024)
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 19, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Accord Healthcare Inc. (Apr 17, 2024)
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.
IssuedApr 17, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Abeona Therapeutics, Inc. (Apr 16, 2024)
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedApr 16, 2024
US FDA• FDA-regulated product
CRLComplete Response Letter
Complete Response Letter Gan & Lee Pharmaceuticals (Apr 12, 2024)
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 12, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Accord BioPharma Inc. (Apr 5, 2024)
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 5, 2024
US FDA• ENNUMO

Complete Response Letter Dr. Reddy’s Laboratories SA (Apr 19, 2024)

Complete Response Letter Xbrane Biopharma AB (Apr 19, 2024)

Complete Response Letter Accord Healthcare Inc. (Apr 17, 2024)

Complete Response Letter Abeona Therapeutics, Inc. (Apr 16, 2024)

Complete Response Letter Gan & Lee Pharmaceuticals (Apr 12, 2024)

Complete Response Letter Accord BioPharma Inc. (Apr 5, 2024)