Beyond the Drug Model: Evidence-Based Dosing, Clinical Outcomes, and the Case for a New Regulatory Framework for Exosomes
- Evaluating exosome dosing strategies: concentrations, delivery methods, and clinical outcomes across multiple conditions
- Understanding Why FDA drug approval models don’t fit acellular biologics — and how the ADDSB framework offers a risk-proportional alternative
- Honing state-level exosome regulation trends and the legislative gap excluding acellular products despite their safety profile and signalling role