Category Archive: eCTD

Jul 02

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 held in July is also listed below with a link to more information. Special Interest …

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Feb 19

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 everything to do with it. There are many guidances on the content of granular electronic …

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May 20

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 the new Module 1 in Q4 of 2014. As a more definite timeline seems to …

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Jan 11

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 Data for CDER’s Inspection Planning Providing Submissions in Electronic Format — Summary Level Clinical Site …

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Jan 11

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 Data for CDER’s Inspection Planning Providing Submissions in Electronic Format — Summary Level Clinical Site …

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Jan 09

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 this revision is information on FDA’s timeline for making eCTD submissions mandatory.  In the recent …

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Jan 09

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 this revision is information on FDA’s timeline for making eCTD submissions mandatory.  In the recent …

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Sep 11

Updated: Free Educational Webinar – Regulatory Electronic Submissions: eCTD v4 Background and Drivers

The FDA is looking to mandate electronic submissions in the next few years. At the same time, they and other regulators are looking to upgrade the eCTD standard. Why would the FDA mandate electronic submissions and change the standard at the same time? Jason Rock, Chief Technical Officer at GlobalSubmit, will provide greater insight into …

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Aug 15

FDASIA, Part 4: Drug Supply Chain, Drug Shortages, and Other Provisions

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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Jan 03

FDA Issues New PDF Specifications

In the chaos of the holidays, you might have missed the release of an important new guidance from FDA.  On 20 December 2011, FDA issued version 3 of “FDA Portable Document Format (PDF) Specifications,” fulfilling a promise made at the recent DIA Electronic Submission conference to release the document by year’s end.  This new version …

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