CDER
FDA Staffing Data Reveal Historic Departures in Fiscal 2025
FDA; staffing; departures; fiscal 2025; layoffs; regulatory impact; CDER; CBER; drug approval delays; organizational disruption
FDA Drug Approvals in 2025 Remain Within Recent Averages Amid Agency Upheaval
FDA; drug approvals; 2025; new molecular entities; CDER; CBER; trends; novel drugs
FDA Launches New Submission Program for Rare Disease Gene Therapies via CDER and CBER
CDER; CBER; rare disease; gene therapy; FDA; submission program; accelerated approval; RDEP; regulatory guidance; rare genetic disorders
FDA Seeks Greater Alignment Between CBER and CDER: Makary Informs Industry Leaders
FDA; CBER; CDER; regulatory harmonization; Marty Makary; George Tidmarsh; Vinay Prasad; cell and gene therapy; biologics; pharmaceutical industry
CDER Employees Leave FDA in Droves Amid HHS Overhaul
CDER; FDA; HHS overhaul; employee resignations; layoffs; health policy; restructuring; Robert F. Kennedy Jr.
FDA Acting CDER Head Jacqueline Corrigan-Curay to Retire Amid Leadership Turnover
FDA; Jacqueline Corrigan-Curay; CDER; retirement; leadership turnover; drug regulation; agency departures
About 5% of CBER and CDER Left After FDA Staff Cuts, Analysis Finds
FDA layoffs; CBER; CDER; drug review; biologics; staff cuts; Trump administration; drug approval process