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TOPIC: Off-Label Use and Promotion Protected by Court

Off-Label Use and Promotion Protected by Court 16 Dec 2012 10:37 #21

  • DOV
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This is the same court that is hearing the Cytori v FDA

We all know the FDA used the excuse of lack of a predicate device to deny our 510K application for Celution. The truth is they are afraid of off-label use of the cells. Now that stance is illegal. Can't hurt our case.
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