Lexology April 22, 2024
The FDA, by and through the Center for Drug Evaluation and Research (CDER) announced the new Center for Clinical Trial Innovation (C3TI)[1], to serve as a central hub to support innovative approaches to clinical trials. This will help advance drug development and regulatory decision-making. Existing CDER innovation programs will continue, with C3TI synthesizing lessons learned. C3TI’s mission is to promote clinical trial innovation through enhanced communication and collaboration.
On October 17, 2023, CDER solicited public comments “on the barriers on the barriers and facilitators to incorporating successful on promising innovative clinical trial approaches in drug development programs”. Thereafter a workshop between the public and the FDA, conducted and led by the Duke-Margolis Institute for Health Policy occurred on March 19&...
Today's Sponsors
Today's Sponsor