CDER soliciting comments regarding clinical trial innovation
[10/17/2023] Today, CDER announced that the center is soliciting public comments to understand the state of innovation in clinical trial design and conduct. CDER is gathering information from internal and external stakeholders on the barriers and facilitators to...Questions and Answers on Mifeprex
What is mifepristone and how does it work?Mifepristone is a drug that blocks a hormone called progesterone that is needed for a pregnancy to continue. Mifepristone, when used together with another medicine called misoprostol, is used to end an intrauterine pregnancy...FDA establishes CDER Center for Clinical Trial Innovation (C3TI)
[4/15/2024] Today, FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and...CDER Establishes New Quantitative Medicine Center of Excellence
[03/25/2024] FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce the new CDER Quantitative Medicine (QM) Center of Excellence (CoE). QM involves the development and application of exposure-based, biological, and quantitative modeling and...All Drug Purchases Are
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