The FDA’s draft guidance on Prescription Drug Use-Related Software establishes a regulatory framework for software that supports the safe and effective use of prescription drugs. For pharma, this represents more than a compliance update. It opens a path for software to become a strategic part of the treatment experience.
PDURS offers a structured, predictable way to strengthen patient engagement, differentiate therapies, and add value across the asset lifecycle.
Why PDURS matters
A clear framework for combining digital tools with drug products
PDURS provides clarity on how software can support drug use, whether through patient guidance, dose support, behavioural interventions, or other forms of assistance tied to a prescribed therapy.
Two labelling pathways with meaningful implications
Outputs from PDURS tools can be included in either:
— Promotional labelling, submitted through Form 2253
— FDA-required labelling, when clinical evidence demonstrates a meaningful contribution to outcomes and qualifies for inclusion in Prescribing Information
This creates a pathway for digital features to move from promotional content into core clinical documentation when supported by evidence.
Device-connected scenarios require alignment across regulatory domains
If the PDURS tool connects to a device, there may be additional device submissions and PI descriptions. This means drug and device regulatory strategies must be aligned early and consistently.
A model that enables continuous innovation
Unlike traditional product submission approaches, PDURS supports iterative software development. This allows pharma teams to release new digital capabilities over time while maintaining alignment with the drug product’s regulatory status.
Software can evolve from version one to version two and beyond, strengthening product differentiation without restarting regulatory processes.
How Dawn Health supports pharma teams moving into PDURS
Dawn Health works with US pharma clients and global partners to translate PDURS guidance into actionable digital strategies and product architectures. Our support spans:
1 — Software components structured for PDURS
We help teams design SaMD-based modules that meet PDURS expectations and align with drug-specific needs.
2 — Clinical study design to support labelling outcomes
We provide guidance on evidence strategies that enable meaningful outcomes to be reflected in Prescribing Information when appropriate.
3 — Regulatory clarity across drug and device pathways
We help teams navigate the intersection of drug, device, and software regulation, ensuring alignment across all functions.
4 — A scalable digital foundation that evolves with PDURS
Our modular technology allows teams to introduce new features and value over time without rebuilding from scratch.
Conclusion
PDURS is more than a regulatory development. It is an opportunity to redefine how digital solutions support patients across therapeutic areas. For pharma companies looking to differentiate assets, strengthen patient engagement, or expand the role of digital in the treatment experience, PDURS offers a clear and actionable path forward.
At Dawn, we combine regulatory insight with advanced digital product capabilities to help our partners build PDURS-aligned solutions that create sustainable value for patients, providers, and the assets they support.
