FDA Guidance Raises the Bar for Drug Delivery Evidence

FDA guidance on real-world evidence for devices underscores data quality and may shape how device-based drug delivery systems are evaluated in the US

15 Jan 2026

Drug delivery in the US is entering a phase in which evidence is expected to come not only from trials but also from routine clinical use, as regulators place greater weight on how products perform in real settings.

In December 2025, the Food and Drug Administration issued final guidance on its use of real-world evidence, or RWE, in regulatory decisions for medical devices. Although the document applies formally to devices, it is drawing close attention from drug delivery companies because many delivery technologies are regulated as devices or as part of combination products.

The guidance makes clear that real-world data can support regulatory decisions only when it is reliable, traceable and directly relevant to the question under review. It does not introduce new standards for drugs or biologics, which are covered by separate frameworks, but it may shape how the FDA assesses device components that play a central role in how medicines are administered.

That emphasis is sharpening industry priorities. As more therapies shift toward home care and self-administration, companies are under pressure to show that delivery systems work consistently outside controlled settings. Attention is increasingly focused on whether platforms can generate credible evidence during everyday use, rather than simply demonstrating performance in trials.

Recent dealmaking reflects this trend. Biogen’s acquisition of Alcyone highlights growing interest in delivery devices designed for complex clinical environments, where reliability and precision are critical and where performance data may be closely scrutinised.

Analysts say the FDA’s stance could strengthen the case for delivery systems that embed data capture and validation from the outset. In some circumstances, high-quality real-world performance data could help support product updates or refinements without relying entirely on long, traditional studies, provided FDA expectations are met.

The guidance also underlines the risks. Variability in patient behaviour, inconsistent use and incomplete reporting can all weaken data integrity. The FDA is not signalling a lower threshold for evidence, but higher expectations for how companies control bias and manage data quality.

For drug delivery teams, this translates into practical demands, including greater investment in user-centred design, data governance and partnerships with healthcare systems and technology providers. How well companies respond may influence both regulatory outcomes and the long-term competitiveness of their delivery platforms.