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美国FDA药品评价与研究中心(CDER)于2009年批准了25个新药上市,其中包括19个新分子实体(NME)和6个治疗性生物制剂(BLA)(见表1),而2008年为21个NME和3个BLA,2007年为17个NME和2个BLA。此外,2009年还有4种血液制品和3种疫苗获得FDA生物制品评价和研究中心(CBER)批准。可见近几年
The FDA’s Drug Evaluation and Research Center (CDER) approved 25 new drug listings in 2009, including 19 new molecular entities (NMEs) and 6 therapeutic biologicals (BLA) (see Table 1), while in 2008 21 NMEs and 3 BLAs, 17 NMEs and 2 BLAs in 2007. In addition, four blood products and three vaccines were approved by the FDA for Biologics Evaluation and Research Center (CBER) in 2009. Visible in recent years