FDA issues pharmacogenomics data submission guidance.

摘要

The US Food and Drug Administration (FDA) has issued a final guidance entitled 'Pharmacogenomic Data Submissions.' With several major drugs failing during the past year, the guidance is seen as an opportunity for companies to apply their related technologies and vindicate the use of pharmacogenomics in improving the drug discovery process.The FDA guidance provides information on the correct format for pharmacogenomic data, standard operating procedures that indicate how a company should go about submitting voluntary pharmacogenomic data, and how the voluntary data will be reviewed by a specially created group within the FDA, known as the Interdisciplinary Pharmacogenomics Review Group.