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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FDA Provides Clarification for Organizations Submitting ANDAs

The Generic Drug User Fee Amendments (GDUFA) introduced user fees to the organizations participating in the bioequivalent drug industry and incentivized filing Abbreviated New Drug Applications (ANDAs) electronically. The law functions as an informal mandate by promising expedited review times to applicants who submit to the US FDA in eCTD format. Another GDUFA stipulation addressed the Refuse-to-Receive (RTR) designation for ANDA...

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US FDA Refuse-to-Receive Guidance for Electronic ANDA Submissions

Serious deficiencies in Abbreviated New Drug Applications (ANDAs) will trigger a refuse-to-receive response from the U.S. Food & Drug Administration, and require the applicant to file a new submission and pay an additional fee according to the latest Agency draft guidance. Enhanced refusal-to-receive standards are one of the primary Year 1 program goals under the Generic Drug User Fee Act (GDUFA) which initiates a user fee...

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