De Novo Regulatory Strategy for a First-in-Class PDT
-
First in class Prescription Digital Therapeutic (PDT) required a credible FDA package despite limited precedent.
-
Evidence was distributed across multiple studies and needed to be packaged into a cohesive submission strategy
to achieve a broad label.
- Evaluated regulatory pathway options and organized De Novo pathway support.
- Designed evidence package and submission narrative for FDA engagement.
- Synthesized findings across three clinical trials.
- Mined precedent cases to strengthen classification rationale.
- Developed investor materials aligned to the regulatory story.
- Established a clear regulatory pathway for a novel product category.
- Improved coherence and defensibility of the submission narrative.
- Enabled consistent communication across regulatory and investor audiences.
