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FDA Presentations & Panel from the North American Interchange

One of the traditionally popular sessions of the Interchange is the FDA Panel, which took place on Thursday, 4 November, in Baltimore.  In the prior session that afternoon, chaired by CDISC Technical Architect, Dave Iberson-Hurst, presentations were made by Dr. Vicki Seyfert-Margolis, Senior Advisor of Science and Technology, Office of the Commissioner; Amy Malla (CBER);  Dr. Chuck Cooper (CDER/Computational Science Center) and Dr. Steve Wilson (Biometrics, CDER).

Final Notes from the North American Interchange by Dr. Rebecca Kush

Additional activities that took place at the Harborside during the week of 1-5 November included a meeting with FDA representatives to discuss ‘derived variables’ and how best to incorporate these into a submission, SDTM, ADaM...

The State of the CDISC Union: Creating Value and Ensuring the Future for CDISC by Dr. Rebecca Kush

“…..here’s the thing:   if I give my song away to 20 people and they give it to 20 people, pretty soon they know me and my value as a creator is dramatically enhanced.”
“The best way to raise demand for your product is to give it away.”

Both of these quotes, which I used to open my presentation at this year’s North American Interchange, were from John Perry Barlow--- the first as the lyricist for The Grateful Dead in the ‘70s and the second for Wired Magazine in 1994.

2010 North American Interchange - Keynote Highlights by Dr. Rebecca Kush

Dawn over the Baltimore harbor was spectacular from the Renaissance Harborside. We are most grateful that our three keynote speakers were willing to drive into the city while the sun was yet rising to deliver a superb opening session to the CDISC Interchange.

Just Do It! Dave Iberson-Hurst reflects on the North American Interchange

It has been a week or so since I returned from the US Interchange and I thought it timely to write a short blog about the work that CDISC does and, more importantly, the people who, in the words of one rather well know sports goods manufacturer, Just Do It.

China, Part 2 of CDISC in Asia by Rebecca Kush

Yesterday, we posted Dr. Kush's experiences in Korea, today she and her two companions, Pierre-Yves Lastic and Sheila Leaman have reached China.  Here they meet with the CDISC China Advisory Council (CCAC), a new and important group. They also managed to visit one of China's most famous landmarks.

FDA, CDISC Standards and the Critical Path by Rebecca Kush

June has been a month full of interesting meetings, events and activities for CDISC.  In particular, Bron Kisler and I attended a set of meetings in the Washington, DC area 8-11 June while others within CDISC met face-to-face in Philadelphia to advance the CDISC SHARE project. 

FDA CDER Data Standards Plan V 1.0 and PDUFA IV IT Plan Update Released By Dr. Rebecca Kush

Two new documents relevant to CDISC have now been posted to the FDA website and one announced in the Federal Register.  In this blog are a few highlights that I have pulled from each of the documents…but, please read them yourselves and  please sign up to attend the webinar on 29 June to hear directly from CBER and CDER representatives, Amy Malla and Dr. Chuck Cooper.

Dr Rebecca Kush - Voices from the CDISC FDA Town Hall Meeting

The CDISC INTRAchange was launched this year on the evening of 23 March, following the DIA FDA CDER/CBER Computational Science Annual Conference, with a CDISC FDA Town Hall Meeting.  Frank Newby welcomed everyone and introduced the FDA representatives ...

Clear Messages from FDA CDER and CBER

by Dr. Rebecca Kush

There are some very clear messages coming from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).  As of a meeting with CDER and CBER Representatives and the CDISC Executive Committee on 1 February ....

Rebecca Kush - FDA Messages from the Interchange: Use CDISC Standards Now

In the prior CDISC Blog, Dave Iberson-Hurst explored the ‘disappearing’ timelines for the HL7 transport mechanisms for CDISC content.  Since these HL7 standards (which by the way will be co-owned by CDISC and HL7 if and when they are ready) are not yet available nor tested, what does FDA want to see now (TODAY) when it comes to data standards? ...

The FDA, HL7 and a Disappearing Timeline

It might not have been a presidential debate but the closing session at the North American Interchange was no less intriguing. The session was an FDA panel that opened with a speech from the FDA Deputy Commissioner Dr Sharfstein ...

Chris Tolk, Reports from FDA at White Oak

I attended the Coalition Against Major Disease (CAMD) Coordinating Committee Meeting at the FDA’s White Oak Campus this week. The initial goal of CAMD is to define clinical data standards and establish a pooled database of the control group of pharmaceutical clinical trials in order to develop quantitative disease progression models for both Alzheimer’s and Parkinson’s disease ...

Rebecca Kush, Bringing the Puzzle Together

November is suddenly upon us and I am wondering where the first 10 months of the year have gone. While welcoming the earlier sunrise (and the end of daylight savings, which brings no favors to those of us who live in the hotter areas nearer the equator), there is reason to reflect on what CDISC has done in the past 10 months of 2009 and where we are going in 2010. There have been many opportunities to do this recently...