Dr. Vinay Prasad, the controversial critic of the US Food and Drug Administration who took a top role at the regulatory ...

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 ...

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 FDA leadership team’s hesitancy on Trump’s nCoV-2019 vaccines and hydroxychloroquine somehow didn’t apply to Biogen’s Aduhelm (aducanumab) review. The same career FDA bureaucrat who ...

Patrizia Cavazzoni is director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. Billy Dunn is director of CDER’s Office of Neuroscience. Peter Stein is ...

Sen. Bill Cassidy, MD (R-La.), called for this week's planned meeting of the CDC's Advisory Committee on Immunization Practices to be delayed, saying its new panel picked by HHS Secretary Robert F ...

CDER’s new Office of Pharmaceutical Quality (OPQ) will be the center’s single unit dedicated to the purpose, and will begin operations on Jan. 5, 2015.

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 ...