Five Points to Consider When Selecting an Enterprise eCTD Viewer
Oct16

Five Points to Consider When Selecting an Enterprise eCTD Viewer

When selecting a system for cross-department viewing of eCTD submissions, as well as archiving, here are some important points you’ll want to give proper attention.

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Australia Set for eCTD Submissions Pilot Program
Jul01

Australia Set for eCTD Submissions Pilot Program

The Australian Therapeutic Goods Administration (TGA) appears ready to proceed with a pilot program that will pave the way for full adoption of eCTD submissions.

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FDA Online Instruction for eCTD Submissions

The CDER Small Business Assistance Program recently posted a web-based training course on electronic submission in eCTD format. The primary goal and purpose of CDER’s training is to encourage sponsors to submit in eCTD format. The training explains the FDA’s policies and practices regarding electronic submissions and provides sponsors with the fundamental information needed to submit new and transition old applications to...

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Converting a Paper IND to eCTD Format
Jan22

Converting a Paper IND to eCTD Format

Conversion of a paper IND to eCTD format can be done at any time the sponsor is ready to implement eCTD. It is important to note that once an eCTD submission has been made to an application all subsequent submissions to that application must also be in eCTD format. Typically, the first submission sent to the application as an eCTD will contain the appropriate form (1571 or 356h) and cover letter indicating that all future submissions...

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RAPS 2012 Attendees Focused on Electronic Submission Mandate

I recently attended the RAPS 2012 annual meeting in Seattle, and had the opportunity to speak with many different regulatory professionals from all over the country. One of the main themes that seemed to be on everyone’s mind was the impending PDUFA V mandate on electronic submissions. Based on the information gathered from the sessions and around the exhibit area, it is clear that there is some trepidation as to how to manage...

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