October 1, 2003, FDA将大部分原由CBER (Center for Biologics Evaluation and Research) 审批的生物药物，转移到CDER (Center for Drug Evaluation and Research) 进行审批。FDA 希望籍此进一步发展这两个中心之间的科学与管理合作，使药 物的审批更有效和一致。留在CBER的生物药物主要为疫苗 ...

2009 approval highlights One such product that was approved by CBER, but not CDER, was recombinant human antithrombin (ATryn; GTC Biotherapeutics) for the treatment of hereditary antithrombin ...

Report on Research Compliance 17, no. 5 (May 2020) - Study sponsors should be making additional efforts to enroll older individuals in cancer trials, incorporating such strategies in study design ...

"A major stimulus for developing this new office was the transfer of review of many therapeutic biologic products from CBER (the Center for Biologics Evaluation and Research) to CDER" last summer, ...

Further, many biologics are manufactured using biotechnology. CDER promotes and protects the public's health by ensuring that all prescription and nonprescription drugs marketed in the United ...

Five of FDA’s centers and offices published their CY 2025 guidance agendas in early to mid-January: the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and ...

It will be co-led by Patrizia Cavazzoni, director of the FDA's Centre for Drugs Evaluation and Research (CDER), and Centre for Biologics Evaluation and Research (CBER) director Peter Marks.