Does SEND include any skeuomorphs? Okay, strange word I know – stay with me….. Why does my phone make the sound of shutter when I take a photo? It doesn’t have a shutter, and even if it did, I wouldn’t be able to control its volume level. Yet, I hear that satisfying old school shutter …
Tag Archives: SENDIG-DART
Is the world of SEND moving too fast?
Well, March 2021 turned out to be a big month in the world of SEND. The FDA issued their 90-day notice for the enforcement of the Technical Rejection Criteria (TRC) for Study Data. This means that the FDA will begin rejecting studies that don’t meet the criteria effective September 15, 2021. We also had a …
Supported but not required by FDA – What’s the point?
SENDIG-DART v1.1 is currently supported by FDA, but not actually required, so should anyone really care? What’s the point of a standard that isn’t required yet? In this context, supported means that a sponsor could choose to include SEND datasets, and the FDA are willing and able to receive them and would expect to use …
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DART, SOT & an FRN – Just another week in the world of SEND
First, I noticed that I was getting a lot of email notifications and messages. More than usual. Something happened and the news was spreading. It was a Federal Register Notice (“FRN”) and it honestly came as a bit of a surprise. It was announcing that the FDA were adopting SENDIG-DART and stating they would start …
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The DART pilot is getting ready to fly: Part 2
In Part 1, I went into the detail of what the new SENDIG-DART standard covered; and now I’ll conclude by describing what’s involved in ensuring the industry is equipped with the necessary tools and services in order to successfully participate in the FDA’s Fit For Use (FFU) pilot for SENDIG-DART. The view from the trenches …
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The DART pilot is getting ready to fly
It’s here. It’s finally here. It’s actually real. This is going to happen. This is part 1 of a 2 part mini-series, hang in there… I’m referring to the FDA Federal Register Notice for the pilot of SENDIG-DART (that’s SEND for Reproductive Tox). It’s a new SEND standard, and the FDA are going to run …
Sensible SEND Blog 