论文部分内容阅读
Ｈｅｐａｇｅｎｅ是Ｍｅｄｅｖａ公司的一种新的ＨＢＶ疫苗。Ｍｅｄｅｖａ公司在１９９９年２月提请ＦＤＡ对Ｈｅｐａｇｅｎｅ进行许可申请初审时，ＦＤＡ要求公司提供进一步的试验数据，并规定了制造商在进行该药安全性和副反应评价时所用的受试者数目。ＦＤＡ同时还要求公司
Hepagene is Medeva’s new HBV vaccine. When Medeva petitioned the FDA for permission to Hepagene for initial review in February 1999, the FDA requested the company to provide further trial data and set out the number of subjects the manufacturer used to evaluate the safety and side effects of the drug. The FDA also requires the company