Guidance Update

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 Guidance Updates – What’s New in 2020

FDA has released several updates to eCTD Guidances

Drug Master Files: Highlights of the Updated FDA Guidance

On October 18, 2019, FDA released an updated draft Guidance regarding Drug Master Files (DMFs) titled “Drug Master Files Guidance for...

New Draft FDA Guidance: Electronic Format for Medical Device Submissions

On September 26, 2019, the FDA released a new draft guidance document titled “Providing Regulatory Submissions for Medical Devices in...

FDA Ad-Promo Series: Navigating eCTD Submissions for Accelerated Approval Products

Background on Subpart H/E Products For life-threatening diseases where there is no current marketed treatment, the FDA may allow for an...

FDA Ad-Promo Series: The Guidance Has Been Finalized – What’s Next For Sponsors?

On June 21, 2019, FDA released the Finalized Guidance for Promotional Labeling and Advertising Materials for Human Prescription Drugs....