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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Thinking Beyond eCTD Publishing
Mar06

Thinking Beyond eCTD Publishing

While finding the right publishing vendor provides tremendous value to an organization short on internal resources, it is important to be thinking beyond eCTD publishing. Pairing with a vendor that can offer extensive regulatory and communications strategy, science and solutions experience brings numerous synergies.

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Is Your Company Prepared for the FDA eCTD Mandate?
Feb06

Is Your Company Prepared for the FDA eCTD Mandate?

Here we are in 2018, and to the surprise of some and the consternation of many, some paper applications are still alive and well. However, their days are numbered. The May FDA eCTD mandate is upon us. Is your company prepared to implement the FDA’s regulations for eCTD submissions of INDs, NDAs and DMFs?  

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FDARA Marketing Status Reports Due
Jan31

FDARA Marketing Status Reports Due

Time is running out for an item that may require your regulatory compliance attention. By law, FDARA marketing status reports are due on or before February 14, 2018.

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Scanning, a Thing of the Past
Apr18

Scanning, a Thing of the Past

Nowadays the word “scan” is a bad word. Scanned documents are more difficult to read and often the quality is lower. Further, scanned documents do not allow search or copy and paste text. During an electronic review, the ability to search and cut and paste text are very useful. Sponsors are reporting more and more rejections if scanned documents are submitted.

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Submitting eCTD in Advance of a Milestone Application
May10

Submitting eCTD in Advance of a Milestone Application

Many people erroneously believe that your first eCTD submission is restricted to a major milestone application – Investigational New Drug (IND) application, Biologics License Application (BLA) or New Drug Application (NDA). That’s simply not the case. It’s 100% possible to file pre-NDA meeting requests, meeting packages and meeting minutes via eCTD in advance of the original NDA submission.

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