FDA Releases Draft Guidance for Regulatory Considerations for Prescription Drug-Use-Related Software

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The agency differentiates between software that has a notable impact on the effectiveness and safety of drug use.

Pharmaceutical companies are embracing new technologies that could potentially assist patients with taking medication in a safe and effective manner.

In 2018, FDA began soliciting comments for a possible regulatory framework based around these technologies. In September 2023, the agency issued its draft guidance on the subject, explaining how drug sponsors should describe their software both in FDA required labeling and promotional labeling.


For the required labeling, which includes prescribing information, the sponsor can submit evidence to FDA that the software results in a meaningful improvement in a clinical outcome as compared to when the patient takes the drug without using the software. If the evidence supports this, the label should include relevant information about the software and its use.

If the software does not have a meaningful outcome on the use of the medication, then it should not be included on required labeling. In that case, the sponsor will simply have to follow the regulations for promotional labeling and ensure that the information presented, such as in a screen display or text message, is accurate, non-misleading, and balanced.

FDA recognizes various types of software as being prescription drug-use related. This can include apps that act as a digital medication log, or a device-connected product that directly transmits drug use related data.