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FDA Will Release Pharmacogenomics Guidance on Friday, Agency Officials Say

Mar 14, 2005

NEW YORK, March 14 (GenomeWeb News) - The US Food and Drug Administration will release its Guidance for Industry on Pharmacogenomic Data Submissions on Friday, according to two agency officials.

 

Larry Lesko, director of the office of clinical pharmacology and biopharmaceutics at the FDA's Center for Drug Evaluation and Research, announced the day during a presentation at a Drug Information Association conference in Lisbon, Portugal, last week. Lesko and Felix Frueh, CDER's associate director for genomics, both confirmed the date through an FDA spokesperson last Friday.

 

The long-awaited document will appear on a special website that the FDA will launch this week, Federico Goodsaid, an official at the agency's Office of Clinical Pharmacology and Biopharmaceutics,  ///issues/news//125605-1.html"

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