Center for Drug Evaluation and Research Center for Clinical Trial Innovation
The Food and Drug Administration (FDA) is publishing this notice to announce the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI aims to be a central hub within CDER that supports innovative approaches to clinical trials that are designed to improve the quality and efficiency of drug development and regulatory decision making. C3TI's mission is to promote existing and future CDER clinical trial innovation activities through enhanced communication and collaboration. Existing CDER clinical development innovation programs will continue to operate according to their established processes with C3TI serving to synthesize lessons learned across those programs. C3TI will also be providing additional opportunities for sponsors of innovative clinical trials in the project areas described below to interact with CDER staff with the goal of fostering knowledge sharing both internally and externally.
Abstract as published in the Federal Register.
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