The U.S. Food and Drug Administration (FDA) will not narrow the scope of evidence the agency considers relevant when defining a drug or medical device’s “intended use.”
The newly implemented final rule, which took effect Sept. 1, reaffirms the FDA’s wide latitude of discretion in establishing an off-label use case against pharmaceutical and medical device companies. It describes what evidence the agency will consider relevant to determine a drug or medical device’s intended use under the Food, Drug, and Cosmetic Act.
