Hosted on MSN

FDA appoints Tracy Beth Høeg as fifth CDER head this year

The US Food and Drug Administration (FDA) has selected Tracy Beth Høeg as its new head of drug research and evaluation – marking another leadership change in a tumultuous period for the agency. Høeg’s ...
FierceBiotech

FDA names longtime oncology chief Richard Pazdur as new CDER director

In a surprise move, the FDA has named the longtime leader of its oncology department, Richard Pazdur, M.D., as the new director of the Center for Drug Evaluation and Research, which oversees most ...
STAT

FDA’s new top drug regulator hails from industry

John Wilkerson is a Washington correspondent for STAT who writes about the politics of health care. He is also the author of the twice-weekly D.C. Diagnosis newsletter. You’re reading the web edition ...

'Silenced' former FDA leader Rick Pazdur receives standing ovation from S.F. crowd after first appearance since exit

Amid an FDA shakeup and reports about interference in drug and personnel decisions, Pazdur resigned last month after more ...
FiercePharma

FDA leadership churn continues with transfer of OTC drug office director

One day after the FDA’s new director of the Center for Drug Evaluation and Research (CDER), Richard Pazdur, M.D., informed colleagues of his sudden and unexpected retirement, one of his lieutenants ...
Healthcare Dive

Richard Pazdur, FDA drug czar, to retire from agency

Richard Pazdur will retire from the Food and Drug Administration only weeks after being named the head of its main drug review office. A spokesperson for the FDA confirmed that Pazdur, the director of ...
Seeking Alpha

Vanda Seeks FDA Commissioner Review of Outgoing CDER Director's Decision to Uphold Approval of Two Generic Versions of Hetlioz®

WASHINGTON, Aug. 21, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration (FDA) to review ...
JD Supra

Dr. Tidmarsh Resigns as Director of CDER, Leadership Developments in Key FDA Offices, and FDA Announces Reforms to Accelerate Biosimilars

Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics ...
The Indianapolis Star

iTolerance, Inc. Appoints Former Chief of the Laboratory of Biochemistry in the FDA’s Center for Drug Evaluation and Research (CDER), Emily Shacter, Ph.D., to its Scientific ...

Esteemed expert in the regulation and development of biopharmaceuticals, with more than three decades of experience spanning government, industry, and academia MIAMI, FL / ACCESS Newswire / August 21, ...