Mark A. Hewitt –  “Emergency Use Authorization” (EUA) came into prominence with the “Right to Try” law.  This law was another way for patients who had been diagnosed with life-threatening diseases, who had tried all approved treatment options and who were unable to participate in a clinical trial, to access certain unapproved treatments.

What is the difference between FDA Approval and Emergency Use Authorization?

“FDA Approval” from the Food and Drug Administration is an independent, scientifically reviewed approval for medical products, drugs and vaccines.  Approval is based on substantial clinical data and evidence, the product is deemed safe, effective and able to be produced within federal quality standards.
Continue reading →