Drugs

Drug Use-related Software Labeling Guide

FDA has released a draft guidance entitled “Regulatory Considerations for Prescription Drug Use-Related Software.” The document describes the agency’s application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or a drug-device combination that is regulated by CDER/CBER.

According to the guidance, a pharmaceutical drug use-related software generally includes software that: “(1) is disseminated by or on behalf of a drug sponsor and (2) produces an end-user output that supplements, explains, or is otherwise textually related to one or more of the sponsor’s drug products. A software function is any distinct purpose of the software, and end-user output is any material (content) that the prescription drug use-related software presents to the end user (a patient, caregiver, or health care practitioner).” FDA says it considers end-user output a type of prescription drug labeling.

“For prescription drug use-related software, sponsors may propose including information specifying that use of the prescription drug use-related software with the product results in a meaningful improvement in a clinical outcome as compared to use of the product without the prescription drug use-related software (demonstrated by one or more adequate and well-controlled studies),” FDA says. “For example, the evidence may demonstrate that a combination product with device-connected prescription drug use-related software (e.g., a dose-tracking app that relies on data on drug use directly transferred from a device constituent part within the product) leads to a meaningful change in a clinical outcome or validated surrogate endpoint compared to using the combination product without the device-connected prescription drug use-related software.” The agency recommends that such information be included in the Prescribing Information’s Clinical Studies section.

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