Snapshot

The Emergency Use Authorization (EUA) pathway has been developed by the US Food and Drug Administration of United States.

This pathway can be used where “Medical countermeasures” or “MCMs,” which include drugs (e.g., antivirals and antidotes), biological products (e.g., vaccines, blood products, and biological therapeutics), and devices (e.g., in vitro diagnostics and personal protective equipment). MCMs that may be considered for an EUA include unapproved products as well as approved products intended for unapproved uses. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

The assessment timelines vary.