Prasad 称美国早期研究监管过于繁重,对小公司和罕见病往往不合适。
在 FDA 任职期间,我常常同情企业人员讲述的他们被迫跨越的障碍。美国早期研究阶段的监管非常繁重,很多出于善意,但并非都适用。原文 (en)
During my time at the FDA, I was often sympathetic to the people who work at companies who told me about the hurdles they were forced to jump through. The regulation in this early side of research is tremendous in the United States. A lot of it is well-intentioned, but not all of it is fit for purpose.