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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Health Canada Revises Rules for eCTD Submissions
Dec08

Health Canada Revises Rules for eCTD Submissions

Health Canada recently announced revised validation rules for regulatory transactions for electronic Common Technical Document (eCTD) submissions.

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Health Canada Hints at 2018 eCTD Mandate
Jul21

Health Canada Hints at 2018 eCTD Mandate

In a notice posted to its website, Health Canada gave advance warning that the agency is considering an eCTD filing requirement, or eCTD mandate, that would take effect as early as January 1, 2018. Health Canada is asking for stakeholders to submit comments by August 31, 2016. Comments can be sent to ereview@hc-sc.gc.ca.

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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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FDA eCTD Mandate: One Year and Counting
May05

FDA eCTD Mandate: One Year and Counting

Almost five years ago, I wrote a post outlining the process for converting a paper application into an eCTD application with FDA. As the saying goes, the more things change, the more they stay the same. Here we are in 2016, and, to the surprise of some and the consternation of many, paper applications are still alive and well. However, their days are numbered, with FDA’s eCTD mandate for certain application types set to take effect one year from today.

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