Implementing the U.S. FDA guidance on pharmacogenomic data submissions.

The FDA Guidance for Industry: Pharmacogenomics Data Submissions was issued in 2005. This guidance document covers a broad area associated with how and when to submit genomic data to the FDA. Additional tasks associated with genomic data submissions include the implementation of genomic data submissions; the process for qualification of exploratory biomarkers into valid biomarkers; and technical recommendations for the generation and submission of genomic data to the FDA. These tasks have been addressed throughout the past 2 years by a number of initiatives. These initiatives have included the development of the Interdisciplinary Pharmacogenomics Review Group for review of pharmacogenomic data submissions, the pilot process for qualification of biomarkers, and the concept paper on recommendations for the generation and submission of genomic data. These initiatives have contributed to the effective implementation of the Pharmacogenomics Guidance at the FDA.