As is standard procedure with all newdrugapprovals, the FDA worked with the drug's manufacturer to compose the instruction labeling accompanying Tykerb.
作为批准新上市的药物的一个标准程序,FDA将和药物开发公司撰写一个拉帕替尼的使用说明标签。
2
Outsourcing facilities that comply with the conditions for exemption under section 503b are not required to obtain newdrugapprovals.
符合503 B章节规定的豁免条件的外包场所不需要获得新药批准。
3
Optimists can cheer that the FDA is on track (judging from Q1) for more newdrugapprovals this year than last.