Regulatory Publishing Considerations for Literature References

eCTD submissions frequently include literature references that are submitted to support aspects or statements made within the application. The articles that are provided in the submission are typically from scientific or medical journals that have been downloaded by the sponsor from sources such as the publisher or a service provider like Thomson Reuters. Downloaded articles are commonly formatted following a set of standards that do...

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The Use of CDISC Data Standards in FDA Electronic Submissions

The preferred format for submitting standardized study data to CDER and CBER are the Clinical Data Interchange Standards Consortium (CDISC) Foundational Standards, including the Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Standard for Exchange of Nonclinical Data (SEND). In 2011, approximately 30% of unique NDAs received by CDER and approximately 20% of BLAs received by CBER included CDISC/SDTM data....

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Annual Event Joins Electronic Data Management and Electronic Regulatory Submissions

Today’s entry was provided by Emily Onkka, Director of Project Management and Regulatory Operations at GlobalSubmit and new regular contributor to Theectdsummit.com. Based in San Diego, CA, she will be leading GlobalSubmit’s professional eCTD services, including eCTD compilation, ESG transmission, publishing, quality checking, and best practice implementation. Prior to joining GlobalSubmit, Ms. Onkka was Head of Regulatory Operations...

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Q&A Regulated Product Submissions (RPS)
Oct09

Q&A Regulated Product Submissions (RPS)

Jason Rock, Chief Technical Officer at GlobalSubmit, offered great insight into the topic of Regulated Product Submissions (RPS) or eCTD version 4.0 during a free educational webinar jointly hosted by Cato Research and GlobalSubmit, “Background and Drivers to the eCTD Next Major Version / Regulated Product Submission”, on Thursday, October 4th at 1:00 p.m. EDT.

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

Presentation Details: 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 this topic during a free educational webinar jointly hosted by Cato Research...

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