Posted by Michael Wonder on 06 Sep 2025
FDA announces real-time release of complete response letters, posts previously unpublished batch of 89
4 September 2025 - The US FDA today announced that it will release future complete response letters promptly after they are issued to sponsors.
The agency also released today 89 previously unpublished complete response letters issued from 2024 to the present associated with pending or withdrawn applications. Each of these complete response letters detail specific safety and effectiveness deficiencies identified by the FDA as preventing the application from receiving approval.
