The U.S. Food and Drug Administration (FDA) has announced the establishment of the “Center for Drug Evaluation (CDER) Center for Clinical Trial Innovation” (C3TI). C3TI is intended to be a “central hub” within CDER aimed at...more
On Tuesday, the U.S. Food and Drug Administration (FDA) issued a letter warning medical device manufacturers and sponsors of device studies to carefully evaluate the third parties that they engage to conduct performance...more