Articles tagged with “dmf”

FDA eCTD Requirements: A Guide to v4.0 & Submission Rules

Learn the FDA's mandatory eCTD submission requirements, including key deadlines, technical standards, and the transition from eCTD v3.2.2 to v4.0 for NDAs, BLAs

40 min read

1/13/2026

ectd fda requirements regulatory submissions ectd v4.0 nda bla ind dmf ich