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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 ....

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 ...