How to avoid rejection

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 …

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 …

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 …