如果有优先FDA approval 是6到9个月;主要是3 phases trial需要长时间;通过率大约10%
文章来源: 胡雪盐82023-08-03 22:22:33

 

The FDA typically requires Phase 1, 2, and 3 trials to be conducted to determine if the drug or device can be approved for further use. If researchers find the intervention to be safe and effective after the first three phases, the FDA approves it for clinical use and continues to monitor its effects