If you weren't paying attention closely late last week, you might easily have missed a small but important announcement made by the US Food and Drug Administration (FDA). By the end of 2014, it says, ...

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 ...

// an eCTD Module 5 Clinical Study Report package. * Status badge color mapping for eCTD section completeness. * Determine indentation level from eCTD section number ...

// Generates a structured eCTD Module 5 Clinical Study Report (ICH M4E(R2)) // as a multi-section PDF with auto-populated data from VaxEvidence. * Data required to generate an eCTD Module 5 Clinical ...