by Marc Ellison | Mar 1, 2023 | Regulatory Submission, SEND, Sensible SEND
Recently the question was asked “Are bone length measurements in scope for SEND?”, which leads to another interesting question: “Who gets to decide what is in scope for SEND?”. There are two parts to this. Firstly, which data were intended to be covered by the various...
by Marc Ellison | Feb 15, 2023 | Regulatory Submission, SEND, Sensible SEND
From my earliest introductions to SEND, one of the things that surprised me most was just how loose it was. It seemed that at every turn there were choices. The phrase “The sponsor chose…” occurs throughout the implementation guide when describing a particular...
by Marc Ellison | Feb 1, 2023 | Regulatory Submission, SEND, Sensible SEND
Recently, more and more, I’m being asked my opinion about the scope of SEND and if a certain study or even a certain endpoint should be provided in SEND. Clearly, I’m referring to data which do not have an obvious example in the SEND IG. However, the lack of example...
by Marc Ellison | Jan 18, 2023 | Regulatory Submission, SEND, Sensible SEND
Being the first post of the year, I thought it would be good to consider what the year ahead looks like for the world of SEND. The obvious place to start is looking at the standards that are going to become required by the FDA for submission. March will see SEND 3.1...
by Marc Ellison | Dec 21, 2022 | Regulatory Submission, SEND, Sensible SEND
Greetings of the season everyone! As this will be my last post of the year, I thought it would be interesting to look back at a few of the topics featured in the blog during 2022. Back in January I was hoping to see the publication of the SEND standards for juvenile...
