CBER
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
Vinay Prasad Departs FDA Amid Conservative Criticism and Sarepta Gene Therapy Controversy
Vinay Prasad; FDA; departure; Sarepta Therapeutics; gene therapy; Duchenne muscular dystrophy; conservative criticism; CBER; drug approval controversy; Trump administration
FDA Official Says Sarepta Faces Major Hurdles to Reintroduce DMD Therapy Elevidys
Sarepta; Elevidys; FDA; Duchenne muscular dystrophy; gene therapy; CBER; safety concerns; shipment pause; new studies; approval status
FDA’s Top Cell and Gene Therapy Leaders Exit Amid CBER Upheaval
FDA; cell therapy; gene therapy; CBER; Nicole Verdun; Rachael Anatol; Peter Marks; leadership changes; biopharma regulation
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
Revolutionizing Public Health: CBER’s Peter Marks and the Vision to Reduce FDA Visits
CBER, Peter Marks, FDA, public health, healthcare innovation, regulatory affairs, biologics, vaccines, medical devices, preventive measures.