Therapeutic Solutions International Inc (TSOI)

[HIFI]

What does BLA approval mean?
For vaccines and therapeutics (a treatment, therapy, or drug), companies file what is called a “biologics license application”—or a BLA. But before filing an application for a vaccine BLA, development and testing must follow a standard set of steps.Mar 7, 2022

How long does it take for a BLA to be approved by FDA?
As per the Prescription Drug User Fee Act (PDUFA), the FDA agreed to review the majority of BLAs within 10 months of 60 day filing and for the priority submissions it has been cut down to 6 months of 60 day filing date.Jun 3, 2019