FDA issues guidance on apps used with prescription drugs

On October 20, 2026, the U.S. Food and Drug Administration issued new regulatory guidance clarifying how pharmaceutical companies and technology developers can create, distribute, and label digital applications paired with prescription medicines. Software linked to medical devices must generally be included in prescribing labels, while standalone apps require proven clinical benefits. Most patient-facing app content will be treated as drug promotional material.

Scope and objectives of FDA guidance

• ▪On October 20, 2026, the U.S. Food and Drug Administration issued guidance clarifying how drug companies can develop, distribute, and label mobile applications used alongside prescription medicines.
• ▪The FDA's October 20, 2026 guidance seeks to maintain drug safety and effectiveness standards while providing a regulatory framework for software developers.
• ▪The FDA's October 20, 2026 guidance applies to regulatory oversight for both drug manufacturers and technology developers creating digital companion applications for prescription drugs.
• ▪The FDA stated that its October 20, 2026 guidance aims to reduce regulatory uncertainty for pharmaceutical manufacturers and software technology developers.

Labeling requirements for companion applications

• ▪The FDA policy specifies that standalone apps for symptom tracking, reminders, or coaching should be listed on drug labels only if essential for safe use or offering meaningful clinical benefits.
• ▪Under FDA guidance issued October 20, 2026, companion applications linked to medical devices, such as software paired with asthma inhalers, should generally be included in the drug's prescribing label.

Regulation of app displays as promotional material

• ▪Under October 20, 2026 FDA guidance, patient-facing information displayed through prescription drug companion applications will generally be regulated as promotional material.
• ▪Treating companion application displays as promotional material aligns patient interfaces with existing FDA regulatory standards for prescription drug advertising.