USA – FDA releases guidance on labeling of drug use-related software outputs

The US Food and Drug Administration (FDA) has released draft guidance with considerations on how to include software outputs of drug use-related software in prescription labeling.

In the draft guidance, FDA defines prescription drug use-related software as including software disseminated by the drug sponsor or an entity acting on behalf of a sponsor that creates an end-user output that “supplements, explains, or is otherwise textually related to one or more of the sponsor’s drug products.” The agency said it considers end-user output from drug-related software as a type of prescription drug labeling.

FDA initially opened a docket in November 2018 to seek public comments on a proposed framework for regulating software applications related to prescription drug products…