The FDA is experiencing significant leadership changes impacting drug review and development. Acting CDER director Jacqueline Corrigan-Curay announced retirement following recent agency turnover, including the removal of key personnel from the cell and gene therapy office. New appointments, such as Michael Davis as CDER deputy director, occur alongside ongoing policy reforms under FDA Commissioner Marty Makary, who is steering the agency towards stricter approval standards and rapid AI adoption. These transitions signal a period of regulatory recalibration within the U.S. drug approval landscape.