Pathways to approval


The review mechanisms undertaken by the US Food and Drug Administration (FDA) before a licensing decision is made.

FDA pathways to approval differ for different kinds of intervention. For small molecules and hormones, a new drug application (NDA) must be submitted. If the application is for a copy of an existing small molecule, an abbreviated new drug application (ANDA) must be submitted.

For treatments based on a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product or similar, a biologics license application (BLA) must be submitted