US FDA · Final guidance announcement
FDA announces final guidance on prescription-drug companion software
Official source date: · Source checked
FDA describes its final framework for apps used alongside prescription medicines, including when software content is labeling, when prescribing information should reference an app, and what companies should submit.
Who should review this?
Drug sponsors, digital-health developers, labeling and regulatory affairs teams.
What it means for pharmaceutical teams
The policy distinguishes device-connected software from standalone companion apps and discusses how their output and clinical role affect labeling considerations. Teams should assess the actual software use and claims.
Practical review checklist
PharmaEdges reading prompts for your own applicability review:
- Identify the role of software in your prescription-drug offering.
- Review labeling and submission considerations in the final guidance.
- Coordinate proposed app content with the appropriate regulatory reviewers.
Official source and verification
Read the US FDA source (opens in a new tab)
This article summarises the linked official material. The context and checklist are PharmaEdges explanatory commentary, not additional regulatory requirements. The source publication date is separate from this article’s publication date.
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