FDA / PhUSE CSS, Study Data Reviewer’s Guide
During the second session, yesterday, at the FDA / PhUSE CSS meeting, the working group leads gave a quick round up of the work being undertaken by each of the groups and the current state of play. The one item that caught my attention, due to the fact we have been discussing it in the [...]
FDA / PhUSE CSS, A Quick Update
A short post with some reaction and comment on the opening session of the FDA / PhUSE Computational Science Symposium (CSS) meeting currently being held in Silver Spring, Maryland. The opening session of the meeting – I won’t call it a conference as it is a working meeting and the FDA are keen to stress [...]
The FDA and a Document or Five
As we completed 2012 and entered 2013, there seemed to be a lot of activity within the walls of the White Oak campus. Meetings took place, new legislation was enacted and a few guidance documents slipped out while everyone was thinking about the festive season. PDUFA First of all PDUFA. I will not attempt to [...]
A Draft Guidance. Tell Me What Not How
Just a quick post, the first for quite a few months, on a new draft FDA guidance. Back in late December 2010, the FDA released the first draft of an electronic source data guidance and now we have an updated document. The first point to note is that the guidance is still draft and this [...]
An Olympic Summer …
This summer, I have been otherwise engaged. Work was put to one side and I took on a different role, as an Olympic Volunteer at the London 2012 Games. I can remember when London won the Games back in 2005; I was still teaching and pondering how on earth it would work. Life changed though [...]
What I Want, What I Really Really Want
It is not often that you can use lyrics from a Spice Girls hit single for a title but the words do sum up rather well the contents of this post. In a previous post, I mentioned the development of 55 therapeutic area standards being undertaken at the request of the FDA by CDISC and [...]
Churchill, the FDA and a Fall
“When I feel like exercising I just lie down until the feeling goes away.” According to the web this quote is from Robert M. Hutchins (1899 –1977) and according to Wikipedia, he was an educational philosopher, dean of Yale Law School, and president and chancellor of the University of Chicago.
Mad March and the FDA
It has been a busy few weeks for both work and personal reasons. For those who know us, it is lovely to announce that Amanda (AJ) and I got married on the first day of March. Some pictures from a friend can be found here and many thanks from us both to those who have sent [...]
Metadata and Layers
I have been wandering around over the last six months or so with a couple of pictures in my head that I have at last managed to commit to paper. The pictures in question try and explain why we would want to layer our metadata and through the layers link data standards and, ultimately, why [...]
eSource and a Patent
A few days ago I was alerted to a discussion thread on LinkedIn by a good friend. I started reading and became increasingly alarmed by what I found. The thread can be found here. Please read the thread. My concern is based around a commercial organization taking out a patent on work that I consider [...]
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