由于美国药物开发过程太慢而昂贵,因此常常受到批评。许多批评集中在食品药物管理局(FDA)要求制造厂在新药申请(NDA)中提供更广泛的安全性和有效性的数据以及该局对NDA审查期的冗长。虽然如此,FDA1985年批准了30种新药,同时最引人注目地努力简化药物批准过程,加速了新药利用,这就有理由乐观地认为美国的药物批准过程的效率开始接近一个新纪元。 The United States is often criticized for its slow and expensive drug development process. Much of the criticism has focused on data from the FDA that requires manufacturers to provide greater safety and effectiveness in the New Drug Application (NDA) and the agency’s lengthy review of the NDA. Nonetheless, the FDA enacted 30 new drugs in 1985 and, most notably, strived to ease the drug approval process and accelerated the use of new drugs, there is reason to be optimistic that the efficiency of the drug approval process in the United States is approaching a new era.