FDA letter monthly archive

FDA Letters Issued in April 2023

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

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

CRLComplete Response Letter
Complete Response Letter Ascendis Pharma Bone Diseases A/S (Apr 28, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Clinical efficacy and substantial evidence, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedApr 28, 2023
US FDA• YORVIPATH
CRLComplete Response Letter
Complete Response Letter Novo Nordisk (Apr 24, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, 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.
IssuedApr 24, 2023
US FDA• ALHEMO
CRLComplete Response Letter
Complete Response Letter Hugel, Inc (Apr 12, 2023)
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 12, 2023
US FDA• LETYBO

Complete Response Letter Ascendis Pharma Bone Diseases A/S (Apr 28, 2023)

Complete Response Letter Novo Nordisk (Apr 24, 2023)

Complete Response Letter Hugel, Inc (Apr 12, 2023)