Tracy Beth Høeg Named Acting US FDA CDER Director

Date

December 4, 2025

Category

US Regulations

Description

Tracy Beth Høeg, a senior advisor for clinical sciences at the US FDA who took on a vaccine regulatory role that raised stakeholder concerns, has been appointed acting director of the Center for Drug Evaluation and Research. See FDA Announces Leadership Appointments at Center for Drug Evaluation and Research | FDA .  Dr. Høeg will become the fifth CDER Director in 2025.

A physician and epidemiologist, Dr. Høeg was a Visiting Scholar at the Massachusetts Institute of Technology Sloan School of Management and practiced physical and interventional spine and sports medicine before joining the FDA as Senior Advisor for Clinical Sciences in the Office of the Commissioner and the Center for Biologics Evaluation and Research (CBER).

As the announcement refers to Dr. Høeg as the ‘Acting’ Director, it is assumed that the search for a permanent replacement for Dr Pazdur continues.

As part of its CDER modernization implementation, the FDA also announced a new leader of its Office of Nonprescription Drugs (ONPD). Karen Murry, M.D., will serve as director of ONPD and lead its efforts to deliver affordable over-the-counter options.