Director, Center for Drug Evaluation and Research (CDER)
Appears in 1 story
Oversees drug review and pilot participation from CDER
A first-in-human drug trial takes up to two years to start in the United States. In China and Australia, similar trials begin in months. The FDA opened a pilot this week that tests a faster path. Sponsors partner with outside research institutions that help prepare applications, and the agency reviews application pieces as they are completed instead of waiting for a full package.
Updated 20 minutes ago
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