The FDA is scrutinizing its use of surrogate endpoints for expedited drug approvals, with CDER director George Tidmarsh indicating a 'close look' at these criteria to ensure clinical benefit. Additionally, Tidmarsh publicly criticized the safety and efficacy of the drug voclosporin, raising industry eyebrows. Meanwhile, the FDA is dusting off its shutdown preparedness plans amid government staffing concerns, highlighting regulatory uncertainties in the biotech sector.