Approved, investigational or unproven?

What patients should know

Approved, investigational and unproven are different descriptions. They are not interchangeable.

An approved therapy has undergone the regulatory process required by the applicable national authority for a particular indication.

An investigational therapy is still being studied to determine safety and effectiveness for a proposed use.

Participation in a study does not mean that the therapy has already been proven effective.

An intervention may be commercially available while still lacking sufficient reliable clinical evidence demonstrating safety and effectiveness for the condition being treated.

For U.S. patients, it is particularly important to understand that availability of a treatment outside the United States does not mean that treatment has been approved by the U.S. Food and Drug Administration.

Likewise, FDA status in the United States should not be confused with the regulatory authorization applicable within Costa Rica, Colombia or Mexico.