Food and Drug Administration (FDA) policy on investigational new drug (IND) applications

The United States Adopted Names (USAN) staff received notification that, effectively immediately, a policy instituted by the U.S. Food and Drug Administration (FDA), whereby the FDA will not review any USAN request without an Investigational New Drug (IND) application on file.

Therefore, upon receipt of a USAN application without the IND number listed, the submitting manufacturer will be notified that the USAN process cannot begin until an IND has been filed with the FDA and USAN staff is in receipt of the assigned IND number.