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FDA Official Says PGx Voluntary Submissions Guidance to be Made Available Within a Week

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NEW ORLEANS — The US Food and Drug Administration's guidelines for voluntarily submitting pharmacogenomics data 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.

Federico Goodsaid, a staff fellow within the Office of Clinical Pharmacology and Biopharmaceutics, told meeting attendees that the full Pharmacogenomic Data Submissions guidance will be formally released sometime this month.

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."

The 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.

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.

"Known valid [biomarker] data needs to be submitted to NDA according to the guidance," Rice said in an e-mail to Pharmacogenomics Reporter this week. "The exact definition for known valid [biomarker] can also be found in the guidance: simply put, reaching a 'broad scientific agreement' would describe the transition from probable to known (we don't think that in each case a scientific organization or advisory committee will be called).

"And of course, nothing NEEDS to be submitted during the VGDS process — it's voluntary," Rice added.

Once live, she said, the information will be found here.

— CW

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