RAPS: Genomic Data and Drug Development: EMA Offers New Draft Guidance

As the push for personalized medicine garners more attention, the European Medicines Agency (EMA) on Monday released new draft guidance to provide industry with more insight on how to identify and understand genomic factors that influence drug responses. The aim of the guidance, according to EMA, is to lay out the requirements related to the choice of appropriate genomic methodologies during the development and lifecycle of a drug.