Drug Approval Process的意思|示意

They also wanted stronger protection for their patents against unfair competition, and modifications in and acceleration of the product-approval process of the Food and Drug Administration.

他们还希望他们的专利得到更加强有力的保护，来应对不公平竞争，修改并加快美国食品与药品管理局的批准程序。

When drug manufacturers make any change in the production process that may affect the drug quality, they shall submit the change to the original authority for reviewing and approval.

药品生产企业改变影响药品质量的生产工艺的，必须报原批准部门审核批 准。

The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process.

FDA认为这些产品属于新药，因此必须经过FDA的药品审批（才可销售）。

During the FDA hearing itself, several panel members conveyed an escalating disillusionment with the FDA's drug-approval process.

在FDA听证会期间，几位委员会成员表达了对FDA药物审批程序需要改进的看法。

Plain and simple, the FDA needs new blood. The agency needs to inject a dose of fresh scientific talent and critical thinking into the drug assessment and approval process.

简单明了的说，FDA需要补充新鲜的血液，该机构需要注入一批新鲜的科学人才和关键的技术力量到药物的评估审批程序当中。

When drug manufacturers make any change in the production process that may affect the drug quality, they shall submit the matter for examination and approval to the original approval authority.

药品生产企业改变影响药品质量的生产工艺的，必须报原批准部门审核批准。