The terms “approval,” “authorization,” and “clearance” are often used interchangeably in discussions of the COVID-19 vaccines. What do they really mean? Let’s take a closer look.
An Emergency Use Authorization allows for the short-term use of a medical product.
The FDA expects that the sponsor will be building a formal Biologic License Application (BLA) for when the public emergency has passed.
“Approval” refers to the approval of a full application package:
Clearance is a more abbreviated process than an approval
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