Navigating the FDA’s Emergency Use Authorization Process

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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.

Whether you are seeking FDA authorization, approval, or clearance, Pharmatech Associates can help you along the way. Contact us today!

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