Monday, November 1

FDA Pharmacogenomic Guidance to be Released

From GenomeWeb Daily News:

"The US Food and Drug Administration's final guidance for pharmacogenomic data submissions is finished and will be issued as soon as final legal and other reviews of the document are completed, Larry Lesko, director of the FDA's Office of Clinical Pharmacology and Biopharmaceuticals said yesterday.

Release of the guidance, which industry believes may spur the development and use of new pharmacogenomics technologies, has been delayed because of legal review and because four FDA centers that are 'signing off' on the document, said Lesko."

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