> What is the difference between FDA approved and an emergency use authorization, from the perspective of the law?
> Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions[1]
The difference is that something pushed out under EUA is _not_ FDA approved. So any laws related to approved medicine, devices, vaccines, etc do not apply automatically to EUA products.
> Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions[1]
The difference is that something pushed out under EUA is _not_ FDA approved. So any laws related to approved medicine, devices, vaccines, etc do not apply automatically to EUA products.
[1] https://www.fda.gov/vaccines-blood-biologics/vaccines/emerge...