CBER
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.