FDA letter monthly archive

FDA Letters Issued in June 2023

Name: FDA Letters Issued in June 2023
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in June 2023. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Impax Laboratories, LLC (Jun 30, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Bioequivalence and pharmacokinetics, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 30, 2023
US FDA• CREXONT
CRLComplete Response Letter
Complete Response Letter Regeneron Pharmaceuticals, Inc. (Jun 27, 2023)
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.
IssuedJun 27, 2023
US FDA• EYLEA HD

Complete Response Letter Impax Laboratories, LLC (Jun 30, 2023)

Complete Response Letter Regeneron Pharmaceuticals, Inc. (Jun 27, 2023)