by Marc Ellison | May 11, 2022 | Regulatory Submission, SEND, Sensible SEND
In my last posting, we were talking about the CDISC working conference where I mentioned that one of the highlights of the week was the FDA public webcast. In the past, sometimes these have included surprising announcements which have generated a flurry of activity as...
by Marc Ellison | Apr 27, 2022 | Regulatory Submission, SEND, Sensible SEND
This is the week of the CDISC Spring SEND Virtual Face-to-Face meeting, and yes that’s still an oxymoron, but hopefully this will be the final time as future Face-to-Face meetings are planned to back in person again. While tee week mainly focuses CDISC volunteers on...
by Marc Ellison | Apr 13, 2022 | Regulatory Submission, SEND, Sensible SEND
For a variety of different reasons, at several times this last week, I’ve reiterated my motivations for being a CDISC volunteer. I’ve discussed how I first fell into volunteering almost accidentally, not knowing what I was getting into, and discovering I had a real...
by Marc Ellison | Mar 30, 2022 | Regulatory Submission, SEND, Sensible SEND
This week I caught up with my colleague and fellow SEND obsessive, Mike Wasko. I asked him for his opinions on the FDA feedback letters that sponsors receive after IND submissions. Specifically, his thoughts on their importance and impact – Here’s what he had to say:...
by Marc Ellison | Mar 16, 2022 | Regulatory Submission, SEND, Sensible SEND
So here we are again in March, probably the most significant month in the SEND calendar. At Instem we are busy gearing up for the Society of Toxicology meeting, which will finally be in person again after a two-year hiatus, what with you-know-what. March also means...
