CDER Outlines Drug Safety Measures Taken in 2020

“The past year was an unprecedented one,” says Patrizia Cavazzoni, MD, acting director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA), in a new report on the center’s activities in 2020. She notes CDER “collaborated closely with colleagues across the [FDA] as well as other […]

Jim Kremidas, Executive Director, ACRP

ACRP Calls for Renewed Efforts to Diversify Clinical Trials Workforce

Calling for a concerted effort to promote diversity in the clinical trials workforce, Association of Clinical Research Professionals (ACRP) Executive Director Jim Kremidas yesterday (February 3) said that now is the time to raise awareness of clinical research as a vibrant career option among minority populations too often overlooked by the drug and device research […]

Leverage Past Performance to Raise the Quality Bar in Clinical Studies

William Shakespeare likely wasn’t thinking of clinical trials 400 years ago when he wrote “the past is prologue” in The Tempest. But for Lisa Haney, BS, CCRC, senior clinical quality specialist at Medtronic, the bard might as well have been. While it can be difficult, especially during a pandemic, to get above day-to-day functioning on […]