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Food and Drug Administration (FDA)

Why hasn't the FDA more actively promoted CDISC standards

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  • 18 May
It has always been a mystery to me why the FDA hasn't more enthusiastically embraced and offered incentives for NDA submissions to conform to the CDISC standards (A bit of this mystery was lifted for me at the CDISC INTRAchange in March). The INTRAchange is a meeting of the core CDISC participants and Dr. Theresa Mullin, Director of Planning and Informatics at FDA/CDER, spoke about the data review process at the FDA. The FDA uses their Janus software as a repository to store the data, but they allow the reviewers to use different end-user tools to generate their views or develop their own code for analysis purposes.
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Eyjafjallajökull volcano in Iceland – Has this volcano affected your clinical trial?

Multinational Clinical Trials vs Mother Nature

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  • 17 May

We all know someone who has been impacted recently by the ash from the Eyjafjallajökull volcano in Iceland.

Source[01]: Wikipedia, photographer: Henrik Thornburn

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Integrating Clinical Trial Data to Bring Products to Market Faster

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  • 14 May
All clinical trial data is digital. We have to submit it to the FDA in a digital manner but it currently gets there in a disparate manner with many systems involved. What is needed to bring products to market faster is what is now known as a "clinical ecosystem." This was something I wrote about before this great term was coined. The concept is that new product development can take place faster through the ongoing integration of electronic data within a clinical ecosystem.
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