Congress passed laws that expanded the FDA’s authority and toughened requirements for new drug applications.
国会通过了扩大 FDA 权力和加强新药申请要求的法律。
英语百科
New drug application
The Food and Drug Administration's new drug application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following: