Until April 19, 2011 FDA is taking comments regarding the recently issued PGx Draft Guidance. The guidance documentation was written to provide recommendations to drug manufacturers regarding how genomic information can be used during the drug development process. According to GenomeWeb News the draft's primary purpose is "...helping drug developers evaluate how human genomic variations can affect the way drugs function in different people and how they can cause varying clinical responses."1 Also according to GenomeWeb News, "The specific goals of this document...is to provide advice related to general principles of study design, data collection, and data analysis when using pharmacogenomic approaches in pharmaceutical development."2
Learn more about the new guidance:
PGx Guidance Document.