I reckon it's a surety.
Do some research on it. It's different to Australia.
https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
This is now old but if you click around and do additional research on what is happening in Mexico and Puerto Rico, you may come to a different conclusion of what will/may happen next: https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies
I reckon it's a surety. Do some research on it. It's different...
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