New CDER director taking on a center in crisis

George Tidmarsh, the newly appointed director of FDA’s CDER, is inheriting an organization in crisis. His success — and that of the U.S. drug development ecosystem — will depend in large measure on his willingness to acknowledge the severity of the situation, halt and reverse the exodus of agency reviewers, and manage the upcoming PDUFA reauthorization process.

Although the initial firings and layoffs at FDA by the Department of Government Efficiency (DOGE) are long over, a wave of resignations, both recent and impending, threatens the Center for Drug Evaluation and Research’s ability to function, according to FDA officials who spoke with BioCentury and were granted anonymity to speak candidly. Low morale is compounding the problem, limiting managers’ capacity to motivate remaining staff to fill the gaps left by their colleagues, the officials said...