Everything to know about US FDA’s new guidance on apps used with prescription drugs

On Tuesday, the US issued guidance intended to outline drug development pathways and to distribute and label apps alongside their prescription medicines.

The policy highlighted when content in such apps must be submitted to the US Food and Drug Administration when those apps should be referenced in a drug’s prescribing information and the formal revealing of required data, financials or safety records needed to provide to the regulator.

Information displayed to patients through a companion app will be classified as commercial marketing, consistent with the agency’s framework for standard pharmaceutical advertising.

According to Reuters, standalone apps that track symptoms, provide reminders or offer coaching should be listed in the label only if these apps are significant for the medicine’s demonstrating therapeutic efficacy and safety.

In addition, the FDA said the guidance seeks to mitigate regulatory uncertainty for drugmakers and technology developers while upholding strict safety and efficacy benchmarks.

The Director of the FDA’s Center for Drug Evaluation and Research, Michael Davis said: “This guidance reflects FDA’s commitment to responsible, risk-proportionate oversight of digital health, an area that is a key priority for the agency and is evolving rapidly and holds significant promise for improving patient care.”