James C. Shehan, Chair of the firm’s FDA Regulatory practice, tells Law360 there is no cause for concern about the lack of a confirmed FDA commissioner at this point in the Biden administration. He says: "Is it a problem? I'd say no. … The core of the agency continues to function well, so there's no immediate concern." Shehan adds that a confirmed leader is less involved with day-to-day matters and more focused on setting the long-term agenda: "That only happens when you have someone who is officially in charge and is going to be there for a while and says, 'This is something new we should do.’”