CDER
FDA names Tracy Beth Heg as acting CDER chief
Tracy Beth Heg; acting CDER chief; FDA leadership; Center for Drug Evaluation and Research; COVID-19 vaccine safety; drug regulation; U.S. Food and Drug Administration
FDA Breakthrough Designations Lead to Priority Reviews, Report Finds
FDA; breakthrough therapy designation; priority review; drug approval; expedited pathway; biotechnology innovation; rare diseases; oncology; CDER; regulatory science
Can the CDER-CBER Dynamic Change Under New Leadership? Pazdur vs. Prasad in the FDA’s Turbulent 2025
Richard Pazdur; Vinay Prasad; FDA leadership; CDER; CBER; regulatory dynamics; drug approvals; biologics; agency instability; Project Orbis
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