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%

 

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

所有跟帖： 

• 看看每年有多少小药厂消失了就知道了：） -ROA001- ♀ (122 bytes) () 08/03/2023 postreply 22:28:53

• 应该集体搬印度 -胡雪盐8- ♂ (0 bytes) () 08/03/2023 postreply 22:30:20

• 印度的大部分是仿药 -ROA001- ♀ (0 bytes) () 08/03/2023 postreply 22:31:40

• 那得等 7 年以后专利期过后 -HenryLi- ♂ (62 bytes) () 08/03/2023 postreply 22:37:45

• 理论上是，实际好像印度会钻一些空子的，不会卖到美国的。 -ROA001- ♀ (0 bytes) () 08/03/2023 postreply 22:40:04