FDA Leadership Change Aims to Restore Trust in Rare Disease Drug Approvals
The FDA's Center for Biologics Evaluation and Research (CBER) is undergoing a leadership change as Vinay Prasad steps down, amid criticism over the handling of rare disease drug approvals. Prasad's tenure was marked by disruptions and inconsistencies in approval pathways, affecting patients with conditions like Duchenne muscular dystrophy and Huntington's disease. The Senate Special Committee on Aging highlighted these issues, emphasizing the need for consistent regulatory guidance. The upcoming leadership transition is seen as an opportunity to address these challenges and restore trust among industry sponsors and patient advocates. 
