Primary Mode of Action Law and Legal Definition

Pursuant to 21 CFR 3.2 [Title 21 -- Food and Drugs; Chapter I -- Food and Drug Administration, Department of Health and Human Services], primary mode of action is “the single mode of action of a combination product that provides the most important therapeutic action of the combination product. The most important therapeutic action is the mode of action expected to make the greatest contribution to the overall intended therapeutic effects of the combination product.”