What is the difference between approval, authorization, and clearance?
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.
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:
- 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 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.
You may be interested in the following article:
A Comparative Framework Between New Product and Legacy Product Process Validation
This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.