Tuesday, May 24, 2016

EMA Publishes 19-page Guidance on Genomics & Drug Studies

The European Medicines Association (EMA) published a 19 page guidance the use of pharmacogenomics studies in drug development.   Appearing in May, the original PDF document is here and an article summarizing it is available at RAPS, here.  The document includes links to about a dozen prior and related EMA guidances, such as on pharmacogenetics.

EMA is accepting public comments until September 16, 2016.

Links to prior documents (screen shot below; click to enlarge; for real links, see actual PDF guideline.)