如果有優先FDA approval 是6到9個月；主要是3 phases trial需要長時間；通過率大約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： 

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

• 應該集體搬印度 -胡雪鹽8- ♂ (0 bytes) () 08/03/2023 postreply 22:30:20

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

• 那得等 7 年以後專利期過後 -HenryLi- ♂ (62 bytes) () 08/03/2023 postreply 22:37:45

• 理論上是，實際好像印度會鑽一些空子的，不會賣到美國的。 -ROA001- ♀ (0 bytes) () 08/03/2023 postreply 22:40:04