eCTD Module 1 Specification Reminder
O March 1, 2022, the US FDA will no longer be accepting the eCTD Module 1 specification v1.3 (US regional DTD v2.01)
eCTD Module 1 Specification Reminder
eCTD Guidance Updates – What’s New in 2020
Drug Master Files: Highlights of the Updated FDA Guidance
New Draft FDA Guidance: Electronic Format for Medical Device Submissions
FDA Ad-Promo Series: Navigating eCTD Submissions for Accelerated Approval Products
FDA Ad-Promo Series: The Guidance Has Been Finalized – What’s Next For Sponsors?