Cannabinoid-based therapies are reshaping the treatment landscape for patients with rare and refractory seizure disorders. In this exclusive interview hosted by Rare Disease Advisor, Dr. Marcus S. Delatte, former senior pharmacology/toxicology at the FDA’s Office of New Drugs, offers regulatory insight into how these therapies are evaluated for approval—particularly in the context of rare pediatric populations.
What you’ll learn:
- Regulatory expectations for cannabinoid-based products
- Design considerations for rare disease trials
- Challenges in pediatric seizure disorder studies
- FDA’s approach to evidence generation in small populations
Whether you’re advancing a cannabinoid program or developing novel therapies for rare neurological conditions, this discussion provides valuable perspective on regulatory strategy, trial design, and translational science.
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