WASHINGTON--(BUSINESS WIRE)--Greenleaf Health, Inc. (Greenleaf), a leading consulting firm for companies regulated by the Food and Drug Administration (FDA), is pleased to announce that Sarah McGarry, ...

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 ...

The FDA’s influential director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., will soon retire from the agency. The seven-year FDA veteran communicated the decision in an ...

The US Food and Drug Administration said Tuesday that Dr. Richard Pazdur has been named head of its largest division, the Center for Drug Evaluation and Research, which oversees the safety and ...

Tracy Beth Høeg, PhD, appointed as acting director of CDER to modernize the division and enhance cross-center coordination. Dr. Høeg's background includes serving as FDA's Senior Advisor for Clinical ...

A now-deleted LinkedIn post from a top FDA official has raised the hackles of Aurinia Pharmaceuticals as industry watchers puzzle over the official's decision to target the approvability of surrogate ...

WASHINGTON--(BUSINESS WIRE)--Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces that two former senior officials from the ...

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 ...

FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016. On Jan. 22, 2016, FDA’s Center for Drug Evaluation and Research (CDER) announced ...