NEW ORLEANS, March 8 (GenomeWeb News) - The US Food and Drug Administration's guidance for pharmacogenomics data submissions will be available on a special FDA web site within a week, an FDA official said during a lecture at the Society of Toxicology meeting, held here this week.
Crystal Rice, a spokesperson for the FDA's Center for Drug Evaluation and Research, said the long-awaited full document is planned for release "within the next week or two."
One of the major questions that industry members still have about the voluntary submissions guidelines is the process by which individual biomarkers will be defined as "known, valid biomarkers," said Bill Pennie, director of molecular and investigative toxicology at Pfizer.
The FDA currently favors the use of expert advisory committees or public scientific organizations to decide which biomarkers qualify as known, valid biomarkers, said Goodsaid.
The widely anticipated document, whose approval has been delayed numerous times since it was released as a draft in November 2003, is designed to encourage drug makers to use pharmacogenomics technologies in their drug-discovery efforts and submit some of their findings as a way to help the FDA broaden its knowledge of the technologies.