Approval vs Authorization vs Clearance

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.

Authorization

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

“Approval” refers to the approval of a full application package:

• Pre-Market Approval (PMA) for medical devises.
• New Drug Application (NDA) approval for small molecules.
• Biologics License Application (BLA) approval for biologics, including vaccines.

Clearance

Clearance is a more abbreviated process than an approval

• Clinical trials for small molecules and biologics are considered “cleared” if the FDA does not provide negative feedback within 30 days of the Investigational New Drug (IND) application.
• A medical device that is not novel and similar to an already approved device undergoes a process known as 510(k) clearance before entering the market.

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