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, ...
In recent years, the electronic Common Technical Document (eCTD) has become the application type of choice for regulatory professionals operating in the US, EU, Japan and many other markets, offering ...
The author describes several issues in creating drug master files and active substance files for active pharmaceutical ingredients and intermediates. This article covers the submission requirements ...
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