# FDA Issues Prescription-App Guidance

FDA finalized guidance on prescription-drug companion apps, describing how companies should distinguish promotional app content from FDA-required labeling, when an app should be referenced in prescribing information, and what information to submit to the agency. The guidance offers recommendations for drug manufacturers and software developers but announces no procurement funding, contract, or solicitation. Contractors and procurement teams working with these products can use the guidance to inform product reviews and vendor discussions without treating it as a new contract opportunity or a mandatory procurement requirement.

- Drug manufacturers and software developers should review app design, clinical-benefit evidence, labeling, and FDA submission practices against the recommendations.
- Government buyers evaluating related products can account for the guidance’s treatment of app content and prescribing information in technical discussions and product assessments.
- No contract value, solicitation, or funding opportunity is identified in the signal.

**Jurisdictions:** federal
**Industries:** Healthcare, Information Technology
**Topics:** Regulatory Compliance
**Published:** October 20, 2026

### Government Entities
- U.S. Food and Drug Administration (FDA)
- Center for Drug Evaluation and Research (CDER)
- U.S. Department of Health and Human Services (HHS)

### Key Quotes
> Finalizing this guidance gives drug companies and their technology partners a stable foundation to build on as these technologies advance and helps ensure patients and providers can trust the information they receive.
> — Jared Seehafer, M.S., FDA Deputy Commissioner for Technology

### Sources
- [FDA Issues Final Guidance on Prescription Drug Apps and Software | FDA](https://www.fda.gov/news-events/press-announcements/fda-issues-final-guidance-prescription-drug-apps-and-software) - FDA