Category Archives: eCTD

New FDA Guidances for June 2015

By Brant Hamel, Ph.D. and Sheila Plant, Ph.D., R.A.C., Regulatory Scientists at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in June 2015, are posted.  In addition, a single upcoming advisory committee meeting to be … Continue reading

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Authoring for eCTD – Know the Requirements and Think Like a Reviewer

By Jessica Long, B.S., R.A.C., Regulatory Associate II/Submissions Specialist at Cato Research “Before you judge a man, walk a mile in his shoes.”  ― Cherokee Proverb Judgment has nothing to do with this post; seeing things through a different perspective has … Continue reading

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FDA’s New Module 1

Jessica Long, Regulatory Associate/Submissions Specialist In February of 2014, FDA provided an update to the implementation of the revised Module 1 for eCTD submissions on the heels of a few last-minute modifications. Currently, FDA plans to begin accepting submissions with … Continue reading

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FDA’s Last Guidances for 2012

FDA closed out 2012 by releasing several new guidance documents, including: FDA Oversight of PET Drug Products — Questions and Answers Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs Specifications for Preparing and Submitting Summary Level Clinical Site … Continue reading

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FDA’s Updated Guidance Outlines Timelines for Mandatory eCTD Submissions

On 03 January 2013, FDA released a draft revision to the Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications. The most significant update in … Continue reading

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