CDER News & Analysis

FDA (FDA) Changes Top Drug and Biologics Leaders Amid Shakeup

The FDA has made significant leadership changes, appointing Michael Davis to replace Tracy Beth Høeg at the Center for Drug Evaluation and Research (CDER), and Karim Mikhail to succeed Katherine Szarama at the Center for Biologics Evaluation and Research (CBER). These roles oversee critical areas like prescription drugs and vaccines, which contribute to approximately 20% of U.S. consumer spending. The changes follow the resignation of former commissioner Marty Makary amid speculated pressures from President Trump. The FDA is expected to appoint a new permanent commissioner soon, pending Senate confirmation, in light of ongoing turnover issues.