FDA Outlines Goals of Dx-Rx Companion Products; Guidance Expected By End 04 | GenomeWeb

The US Food and Drug Administration will release by the end of the year a draft guidance on the joint development of diagnostic-therapeutic companion products, Larry Lesko, director of the FDA’s Office of Clinical Pharmacology and Biopharmaceuticals, said during a recent meeting.

“We have a guidance now,” said Lesko, referring to the pharmacogenomics data submissions guidelines expected to be made public by the end of the summer. “But we can always do better.”

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