Public Health · 3 h ago
FDA Finalizes Guidance on Apps Used With Prescription Drugs
The FDA has issued final guidance on developing, distributing and labeling apps used alongside prescription medicines. It addresses when app content may be treated as required or promotional labeling, when an app should appear in prescribing information, and what companies should submit to the agency.
- Defines FDA considerations for prescription-drug companion apps.
- Addresses labeling, prescribing-information references and submissions.
- No app-specific evaluation results or clinical recommendations are reported.
The U.S. Food and Drug Administration has released final guidance for drug companies and technology partners developing or distributing apps used with prescription medicines. The agency says the recommendations address when app content is considered FDA-required labeling versus promotional labeling, when an app should be referenced in a drug’s official prescribing information, and what information companies should submit to FDA.
The FDA described the guidance as a framework for both drug-connected and standalone software, intended to support consistent, risk-proportionate oversight while maintaining safety and effectiveness standards. The source does not provide the guidance’s detailed criteria or describe evidence from evaluations of specific apps. It is regulatory guidance for developers and manufacturers, not a clinical study or a change to treatment recommendations.
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U.S. Food and Drug Administration: FDA Issues Final Guidance on Prescription Drug Apps and Software ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.