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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Collection of eCTD Online News, Part 2

A number of good articles related to eSubmissions have been posted online recently. Below, a recap based on posts from my twitter account, www.twitter.com/kathie_clark. Even Richardson of Cato Research posted a useful blog entry, Bookmarks – Collapsed or Expanded? On the “Ask Cato” blog. The entry discusses the FDA reviewers’ preferences for the default expansion of PDF bookmarks. Pharma IQ shared the results of their recent poll, “Do...

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