Posted by Michael Wonder on 16 Jul 2025
FDA embraces radical transparency by publishing complete response letters
10 July 2025 - The US FDA today published more than 200 decision letters, known as complete response letters.
The complete response letters were issued in response to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024, marking a significant step in the Agency’s broader initiatives to modernise and increase transparency.
By making the complete response letters available, the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved.
