Tag Archives: eCTD

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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New FDA Guidances for July 2013

Another month with lots of new and updated guidances released.  Two guidances highlight clinical design considerations for specific therapies: Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases and Considerations for the Design of Early-Phase … Continue reading

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New FDA Guidances for June 2013

FDA was busy last month and released 14 Guidances to prove it, including the long awaited Guidance discussing the Breakthrough Therapy designation that was enacted by FDASIA.  Look for a review of “Expedited Programs for Serious Conditions––Drugs and Biologics” coming … 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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