Advertising and Promotional Submissions Exempt from Coming eCTD Mandate
Apr19

Advertising and Promotional Submissions Exempt from Coming eCTD Mandate

The FDA requirement to submit in eCTD format as of May 5, 2017 does not apply to Ad Promo submissions. As of today, the timeline for requirement of these submissions in eCTD is to be determined. Similar to the majority of regulatory requirement updates at FDA, the date effective clock doesn’t start counting down until guidance is finalized. The key indicator for Ad Promo eCTD submissions is the document titled – Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs. If FDA follows precedent, Ad Promo submissions will be required in eCTD format 2 years after the final guidance is published.

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The End of Paper Submissions
May11

The End of Paper Submissions

The release of the final binding guidance now sets in motion a 24-month timeline. Using the May 5th date as a guide, it stands to reason that submission types NDA, ANDA, BLA, and master files must be submitted in eCTD format beginning May 5, 2017. IND submissions would be required May 5, 2018.

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FDA to Postpone Major Electronic Initiatives
Dec10

FDA to Postpone Major Electronic Initiatives

The requirement to submit certain drug applications in electronic format is at least three years off, and the target date for the implementation of the new Module 1 has been extended yet again according to representatives of the U.S. Food & Drug Administration.

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Educational Webinar Recap: Preparing for the eCTD Mandate

The FDA is planning to mandate electronic submissions in 2014. Since most large pharmaceutical and biotech companies already submit electronically, the greatest impact will be to the smaller companies that do not have substantial IT infrastructure in place and lack the resources of their larger peers. Jason Rock, Chief Technical Officer at GlobalSubmit, offered greater insight into this topic during a free educational webinar,...

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Free Educational Webinar: Preparing for the eCTD mandate

Presentation Details: The FDA is planning to mandate electronic submissions in 2014. Since most large pharmaceutical and biotech companies already submit electronically, the greatest impact will be to the smaller companies that do not have substantial IT infrastructure in place and lack the resources of their larger peers. Jason Rock, Chief Technical Officer at GlobalSubmit, will provide greater insight into this topic during a free...

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