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Alias Born 02/01/2012

Wednesday, June 08, 2016 12:36:39 PM

Re: Rolling inflaton post# 203709

Post# of 369042
The purpose of the advisory ADCOM is essentially for new NDAs and BLAs request for approval. It has become obvious during the new FDA under Dr. Califf that there are a number of new NDA and BLAs in 2016 being approved by the FDA without the advisory ADCOM.

The need for the advisory ADCOM is always at the FDA discretion IF they the FDA needs the additional inputs.
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