Upgrading CDER’s workforce was already underway before the pandemic thanks to the FDA’s 21st Century Cures Act, which Cavazzoni called “a real godsend” and “a game-changer.” ...

The founder and former CEO of several pharmaceutical companies, Tidmarsh was tapped by FDA Commissioner Marty Makary, MD, MPH ...

CDER estimates the seven new RPA projects in development will save 24,000 work hours annually, including those where bots schedule meetings and assign letters. The agency has used RPA for a year with ...

But they didn’t want to be educated on something they couldn’t access. More recently, as biosimilars have been approved, doctors are becoming more interested in learning about them. The ...

Comment Published: 31 October 2014 Paving the critical path of drug development: the CDER perspective Janet Woodcock Nature Reviews Drug Discovery 13, 783–784 (2014) Cite this article ...

Sarah McGarry, M.D., Senior FDA Official in CDER and CBER, Joins Greenleaf Health November 08, 2023 09:00 AM Eastern Standard Time ...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has announced the launch of a new hub focused on promoting innovation in clinical trials. The CDER outlined ...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released a new report on drug safety priorities from 2018, offering last year’s valsartan ...