As is standard procedure with all new drugapprovals, 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
Hao Heping, who headed the department that bestowed licences to manufacture medical equipment, was sentenced to 15 years in prison for accepting money to smooth drugapprovals.
负责给药品企业发放生产证书的部门，在承认收受财物以利于药品批准后，被判处15年监禁。
3
Outsourcing facilities that comply with the conditions for exemption under section 503b are not required to obtain new drugapprovals.