FDA letter monthly archive

FDA Letters Issued in March 2024

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

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

CRLComplete Response Letter
Complete Response Letter Fidelity BioPharma Co. (Mar 29, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 29, 2024
US FDA• ONTRALFY
CRLComplete Response Letter
Complete Response Letter Baxter Healthcare Corporation (Mar 29, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 29, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Baxter Healthcare Corporation (Mar 27, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 27, 2024
US FDA• Unknown Product
CRLComplete Response Letter
Complete Response Letter Gan & Lee Pharmaceuticals (Mar 26, 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.
IssuedMar 26, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Cipla USA, Inc. (Mar 22, 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.
IssuedMar 22, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Regeneron Pharmaceuticals, Inc. (Mar 22, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 22, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Regeneron Pharmaceuticals, Inc. (Mar 22, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 22, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Mapi Pharma Ltd. (Mar 8, 2024)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Safety and adverse events, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 8, 2024
US FDA• GA Depot
CRLComplete Response Letter
Complete Response Letter Accord Healthcare Inc. (Mar 7, 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.
IssuedMar 7, 2024
US FDA• Unknown

Complete Response Letter Fidelity BioPharma Co. (Mar 29, 2024)

Complete Response Letter Baxter Healthcare Corporation (Mar 29, 2024)

Complete Response Letter Baxter Healthcare Corporation (Mar 27, 2024)

Complete Response Letter Gan & Lee Pharmaceuticals (Mar 26, 2024)

Complete Response Letter Cipla USA, Inc. (Mar 22, 2024)

Complete Response Letter Regeneron Pharmaceuticals, Inc. (Mar 22, 2024)

Complete Response Letter Regeneron Pharmaceuticals, Inc. (Mar 22, 2024)

Complete Response Letter Mapi Pharma Ltd. (Mar 8, 2024)

Complete Response Letter Accord Healthcare Inc. (Mar 7, 2024)