On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support hub for innovative approaches to clinical trials designed to improve the quality and efficiency of drug development and regulatory decision-making. Following a public solicitation of comments on the barriers of clinical trial designs, FDA determined that the establishment of C3TI would enhance CDER’s ability to address those barriers and foster innovation.
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