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Five Leaders in One Year: FDA's Drug Center Enters 2026 at a Crossroads

The FDA appointed George Tidmarsh, MD, PhD, to be the nation's top drug official in July. The Center for Drug Evaluation and ...
Pharm Exec

FDA, CDER Weigh Organizational Changes

FDA commissioner Margaret Hamburg has formed a top-level working group to propose strategies for enhancing agency functions and processes, starting with the relationship between FDA Centers and its ...

Vanda Pharmaceuticals Announces Receipt of FDA Decision Letter on HETLIOZ® Supplemental New Drug Application for Jet Lag Disorder

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has received a decision letter from the U.S. Food ...
FiercePharma

Working remotely helped FDA's CDER shape a new and improved workforce, director says. What now?

One surprising consequence of the coronavirus pandemic and its work-from-home zeitgeist? Biopharma companies have been compelled to rethink and perhaps even improve how they operate their businesses.
FierceBiotech

FDA wants to boost trial innovation with new center at CDER

The FDA's Center for Drug Evaluation and Research, or CDER, has established a new center for communication between CDER staff and stakeholders involved in clinical trials, according to an April 15 ...
The Pharma Letter

Vanda’s sNDA for Hetlioz rejected again by FDA

US drugmaker Vanda Pharmaceuticals yesterday announced that it has received a decision letter from the US Food and Drug ...
PMLiVE

FDA establishes new CDER centre focused on promoting clinical trial innovation

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 ...
Pharm Exec

New CDER “Super Office” to Promote Drug Quality

After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research, has administration approval for organizational changes to bolster programs and policies ...
Yahoo Finance

FDA CDER director Patrizia Cavazzoni announces resignation

The US Food and Drugs Administration (FDA) has confirmed that its director of the Centre for Drug Evaluation and Research (CDER), Patrizia Cavazzoni, has announced her resignation ahead of Donald ...