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

June 28, 2010 at 4:51 AM by cdisc

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.


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Tags: PDUFA, Standards, ODM, CDER, CDASH SDTM, CBER, FDA,

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