This past week was the CDISC SEND Virtual Face-to-Face meeting, and yes, I still snicker like a schoolboy at calling something a ‘virtual face-to-face’, but hopefully it’s the last one and by next Spring we can be face-to-face in person. Anyways, as is usual, the highlight of the week was the FDA public meeting. As …
Continue reading “FDA provides more detail on the Scope of SEND”
As you are probably aware, Instem recently acquired PDS Life Sciences and so I’ve been working very closely with my new colleague, Mike Wasko. Mike is a prominent figure within our industry, and this week as we were catching up, we started discussing the question: What is the relationship between the eCTD Study Tagging File …
It’s a basic human need: We want our work accepted and valued. Nobody wants to see their work rejected. It’s so obvious, it almost goes without saying. Worse still would be being rejected by a cold, heartless automated computerized system. That would be soul destroying. However, with the FDA’s latest deadline, automated rejections will start …
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