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FDA to Release Theranostics Draft Guidance in Early 2005

NEW YORK, Nov. 12 (GenomeWeb News) - The US Food and Drug Administration will release a draft of its diagnostic-therapeutic companion product guideline for public comment in February, said Larry Lesko, director of the FDA's Office of Clinical Pharmacology and Biopharmaceuticals at Scientific American's Targeted Medicine conference, held here yesterday.

 

No due date has yet been set for the final companion-product document, which is expected to boost consumption of pharmacogenomic technologies, said Lesko.

 

According to Pharmacogenomics Reporter, a GenomeWeb News' publication, the "theranostics" draft guidance was originally slated for release by the end of the year.

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