FDA Says PGx Guidance Document Should be Released by End of Summer | GenomeWeb

By the end of the summer, drug developers and researchers will have a roadmap document with instructions on how they might voluntarily share genomic data with the US Food and Drug Administration as part of the drug approval process.

“We are currently in the final stages of revising the guidance and are looking to complete it by the end of July,” Larry Lesko, director of the office of clinical pharmacology and biopharmaceutics at the FDA’s Center for Drug Evaluation and Research, told BioArray News last week.

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