The FDA is currently undergoing a major shakeup as Richard Pazdur, the newly appointed director of the Center for Drug Evaluation and Research (CDER), announces his resignation just weeks into his role. His exit follows a tumultuous period marked by internal controversies and criticism regarding agency practices and voucher programs. The resignation has sparked concerns within the pharmaceutical industry about the direction of drug approval processes. In response to this upheaval, Tracy Beth Høeg has been appointed as the acting director of CDER, becoming the fifth individual to hold this position in a year. The situation has raised questions regarding the stability and leadership within the FDA, as industry experts warn of a tipping point for regulatory bodies.