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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? ...