NDA Regulatory Affairs in 2026: Key Processes, Documents, and RA Responsibilities
March 13, 2026
NDA regulatory affairs work turns science into a review-ready submission. An NDA is the formal FDA marketing application for a new drug. FDA first runs a filing check within 60 days to confirm completeness. Then the team reviews the dossier. The CTD’s five-module structure, delivered through eCTD, improves consistency, traceability, and lifecycle management during review.
