New 3rd Acknowledgement for ESG Users
Aug21

New 3rd Acknowledgement for ESG Users

Beginning September 4, 2018, a new third Acknowledgement for ESG users will be sent for all submissions sent to the CBER in eCTD format.

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FDA M1 Upgrade for Ad Promo Submissions
Jun12

FDA M1 Upgrade for Ad Promo Submissions

The M1 initiative, specifically the updated guidelines for Ad Promo submissions, is an example of the FDA gently nudging sponsors to adopt practices that will benefit industry as a whole. The draft guidance on the Ad Promo topic states “the Agency is currently able to process, review, and archive electronic formats in eCTD and firms are strongly encouraged to make such submissions electronically.”

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New Metadata Attributes Part of FDA Module 1 Update
Jun02

New Metadata Attributes Part of FDA Module 1 Update

The FDA’s goal to get safe and effective treatments to patient populations in a timely manner demands a reliable drug approval cycle. Changes to the Module 1 specification align to this goal.

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15 Takeaways – FDA’s New Module 1
May22

15 Takeaways – FDA’s New Module 1

The US FDA is rolling out a new and improved Module 1 in less than three weeks. Are you ready? Here is a regulatory intelligence primer based largely on the information that was divulged at the recent DIA eRI conference in Philadelphia.

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eCTD Validation Criteria v2.2 FAQs

GlobalSubmit recently held an educational webinar on the Understanding the New FDA Validation Criteria. The purpose of the webinar was to provide an overview of the US FDA’s draft version of the new “Specification for eCTD Validation Criteria,” which outlines many of the new error conditions that the FDA will be checking for in the next version of its validation software. During the webinar, facilitated by Daniel Clark, Sr. Manager,...

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