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 ...

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, ...

New York, NY, February 10, 2008 --(PR.com)-- Intrasphere Technologies, a leading consulting firm that provides business-focused services and solutions to life sciences organizations, recently ...

For ten years the International Conference on Harmonisation (ICH) has set about achieving a common format for the dossier that must be submitted to gain approval for medicinal products in all three ...