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Latest News | 11 September 2012

Health Canada Overhauls Guidance for eCTD Module

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Health Canada has released a new guidance document pertaining to the creation of the Canadian Module 1 backbone of the electronic Common Technical Document (eCTD), a standardized pharmaceutical review Read More...


Latest News | 3 August 2012

'Major Updates' to eCTD Module 1 Released by FDA

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The US Food and Drug Administration (FDA) has announced the release of “major updates” to Module 1 of the electronic common technical documents (eCTD), used to supplement all eCTD submissions in the Read More...


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