With the influx of “new drug applications” taking up a larger percentage of labor hours, the FDA had to turn to some other alternatives for help. The agency already has a program in place from the 1990s, called the Prescription Drug User Fee Act (PDUFA), which outlines the guidelines and metrics for the FDA to review a drug. Drug companies pay significant fees to the agency when submitting their applications, which now totals more than $2.8 trillion for trials involving clinical data.
Wow, you made it to the end!。关于这个话题，PDF资料提供了深入分析
其中，核心在研药ACC017的Ⅲ期临床试验已正式启动，首例受试者于2025年11月7日成功入组，计划于2027年完成NDA申报；HIV高端仿制药ADC201、ADC202的ANDA申请均已获受理，原料药上市申请也已获批，即将进入商业化阶段。，这一点在PDF资料中也有详细论述
2 days agoShareSave，这一点在爱思助手下载最新版本中也有详细论述