Practical Metadata and Standards for Clinical Research
Follow us on Twitter
Error: Twitter did not respond. Please wait a few minutes and refresh this page.
FDA / PhUSE CSS, Study Data Reviewer’s Guide
by Dave IH on March 19, 2013 - 0 Comments
Categories: Blog
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 [...]
Read more »FDA / PhUSE CSS, A Quick Update
by Dave IH on March 18, 2013 - 0 Comments
Categories: Blog
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 [...]
Read more »The FDA and a Document or Five
by Dave IH on January 16, 2013 - 0 Comments
Categories: Blog
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 [...]
Read more »