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

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.

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