First, determination of a domestic, military, or public health emergency must be confirmed.
Once a formal declaration of a public health emergency has been made, the EUA Submission process can begin.
A pre-meeting will facilitate a rapid more complete EUA submission.
This involves submitting an EUA request to be reviewed by the FDA.
After reviewing the EUA application, the FDA issues a formal approval or rejection.
Once the public health emergency has ended, the EUA terminates.
The FDA encourages further development of products, working toward FDA approval.
This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.