Navigating the FDA’s Emergency Use Authorization Process

Step 1: Confirm Public Health Emergency

First, determination of a domestic, military, or public health emergency must be confirmed.

Step 2: Declaration of an Emergency

Once a formal declaration of a public health emergency has been made, the EUA Submission process can begin.

Step 3: Pre-EUA Submission

A pre-meeting will facilitate a rapid more complete EUA submission.

Step 4: Submission of EUA

This involves submitting an EUA request to be reviewed by the FDA.

Step 5: Approve/Reject EUA

After reviewing the EUA application, the FDA issues a formal approval or rejection.

Step 6: EUA Termination

Once the public health emergency has ended, the EUA terminates.

Step 7: Begin Formal Regulatory Submission

The FDA encourages further development of products, working toward FDA approval.