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BioGaia AB Receives FDA Approval for Drug Investigation in NEC


Tuesday, 6 Aug 2013 08:00am EDT 

BioGaia AB announced that the Food and Drug Administration (FDA) Office of Orphan Product Development has approved BioGaia's request for investigating the possibilities of developing a drug within the field of Necrotizing enterocolitis (NEC). The approval does not change the standard regulatory requirements and processes for obtaining marketing approval for a product. Consequently, all aspects of the development must be investigated, including the clinical safety and efficacy documentation required for a market authorization. 

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