Month: July 2017

CMC, FDA, IDMP, XML

FDA’s Draft CMC Data Elements – IDMP’s New Buddy?

On July 5, 2017, FDA (United States Food and Drug Administration) published a new document to the Federal Register titled “Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Technologies.” This is a draft document describing data structures that could take the place of much of the eCTD (Electronic Common Technical Document). Public comment is …

Brexit, EMA

What does Brexit mean for Pharmaceutical Companies?

The whole world is holding its breath to see whether Britain’s withdrawal from the European Union, nicknamed “Brexit,” will have a “hard” landing – meaning a strict break with the European common market and open emigration – or a “soft” one, meaning that some parts of the treaty may be maintained. Theresa May, Prime Minister, …