FDA Module 1 Grouped Submissions Q&A
Jun26

FDA Module 1 Grouped Submissions Q&A

The current FDA specifications governing grouped submissions state that Application Type and Submission Type have to agree. Accordingly, you would have no trouble grouping NDA labeling supplements.

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Module 1 Grouped Submissions Explained
Jun19

Module 1 Grouped Submissions Explained

A grouped submission eliminates the need to submit multiple, identical submissions to different applications. For example, a manufacturing part change might impact a dozen applications. In the age of grouped submissions, a new sequence would be created to note the part change, and that sequence would then point to all other applications affected.

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The Undocumented STF Lifecycle Management
Nov12

The Undocumented STF Lifecycle Management

A number of sponsors have recently inquired as to the proper use of the modified-file attributes (operators) when using Study Tagging Files (STFs). Our research has yielded a number of helpful findings on the subject.

The Lifecycle Management section (page 10) of the latest ICH guidance on eCTD Backbone Files Specification for Study Tagging Files incorrectly states that the modified-file attribute of “append” is used to control lifecycle operations of that STF. While the documentation is wrong we don’t expect a timely update.

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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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Understanding GDUFDA

Representatives of the U.S. Food & Drug Administration have not minced words when talking about the effect of the Generic Drug User Fee Amendments (GDUFA). The law that established user fees in exchange for a more predictable review process has been called a “transformational change” on more than one occasion. The transformation is causing growing pains as the Agency chases higher quality Abbreviated New Drug Applications (ANDAs)...

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