As the calendar turned from April to May, a big change came to the FDA. | Katherine Szarama, Ph.D., will take over as CBER ...
The US Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) is again extending an invitation to biologics facilities for participation in its Regulatory Site Visit ...
NanoMosaic, Inc., a leader in advanced analytical technologies for cell and gene therapy development and manufacturing, today announced its strong scientific and commercial presence at the American ...
The FDA and EMA have set out updated regulatory agendas that will shape biologics manufacturing standards in coming years. The FDA’s Center for Biologics Evaluation and Research (CBER) 2026 agenda ...
The US Food and Drug Administration today posted its final "Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format: Lot ...