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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How to Avoid Validation Errors on Scanned FDA Forms
Apr03

How to Avoid Validation Errors on Scanned FDA Forms

Not using electronic signatures to sign Forms FDA 356h or 1571? That’s okay, but you will need to know how to avoid validation errors on scanned FDA forms.

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FDA to Answer ESG Submission Surge with Usability Enhancements
Feb16

FDA to Answer ESG Submission Surge with Usability Enhancements

More than 3 million submissions were received via the ESG in 2015, and FDA representatives are estimating 7 million submissions for the year 2016. The volume increase is quite substantial considering 11.3 million submissions passed through the ESG in the previous 10 years (January 2006 to January 2016). Small user improvements planned by the FDA, and announced at DIA RSIDM 2016, will make life easier for sponsors who are growing more dependent on their Gateway accounts.

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Q&A – Ad Promo Submissions
Jun18

Q&A – Ad Promo Submissions

What has changed is the FDA’s methodology for collecting and organizing metadata associated with each application. The old M1 specifications arranged information in a flat structure, i.e., amendments could be related to other amendments. In the new M1 specifications, metadata is arranged in a hierarchy.

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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 The draft guidance on the Ad Promo topic states “the Agency is currently able to process, review, and archive electronic formats in eCTD and firms are strongly encouraged to make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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