Center for Biologics Evaluation and Research
Coverage of Center for Biologics Evaluation and Research in the Nexus archive.
- Opinion: STAT+: Dark times ahead at the FDA
FDA Commissioner Marty Makary was ousted along with Tracy Beth Høeg (CDER leader) and Katherine Szarama (CBER acting director), leaving three crucial FDA positions with only acting leadership. The simultaneous removal of these three high-ranking officials is characterized as an unprecedented ideological purge that has created significant instability within the agency.
- My son has a terminal disease — why FDA delays are failing families like mine
A mother caring for her son with Duchenne muscular dystrophy criticizes the FDA for regulatory delays in approving experimental drugs, arguing that bureaucratic caution harms terminally ill children. She calls for FDA Commissioner Dr. Martin Makary to address the issue and appoint a successor to Dr. Vinay Prasad who prioritizes patient access over caution.