FDA Opens Expedited IND Rolling Review Pilot

Company U.S. Food and Drug Administration Event Type Regulatory Policy (New Pilot Program) Modality Cross-Modality Regulatory Process (IND Review Framework) Asset Expedited IND Rolling Review Pilot Target Pre-IND / First-in-Human IND Review Workflow Disease Area Disease-Agnostic (Novel Modalities Prioritized: Gene Editing, Cell Therapy, RNA Delivery)…