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 ...

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 ...

Drug approval is the goal of the long process of drug development. Once preclinical and clinical trial data have been collected, a New Drug Application must be submitted to the regulatory authority ...