FDA leadership told BIO 2026 attendees it is accelerating hiring to rebuild capacity after last year’s workforce disruptions. Acting chief of staff and deputy commissioner Lowell Zeta said the agency has secured 600 new hires so far and is seeking roughly 1,600 additional staff, with total hiring plans around 2,200. The discussion tied the staffing effort to efforts to stabilize operations and rebuild institutional knowledge, including morale and retention initiatives following rapid leadership turnover and departures. Acting CDER director Michael Davis described onboarding as moving “within historical norms,” pointing to a change in recruitment attendance patterns at orientation sessions. The broader context was workforce reductions linked to the Department of Government Efficiency cuts, with FDA leadership framing hiring and retention as prerequisites for planned regulatory initiatives and to avoid backlogs. Why it matters: FDA’s ability to process submissions, manage timelines, and maintain reviewer expertise is a direct determinant of clinical development speed and how biotech companies plan trial and regulatory strategy.