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ALERT: FDA s PGx Guidance Delayed Until End of Summer


FDA's Lesko: Pharmacogenomics Guidance Delayed Until End of Summer

The US Food and Drug Administration's much-awaited guidance for pharmacogenomics data submissions will be completed by the end of the summer — at least two months later than the FDA had originally anticipated — according to an FDA official.

“We’re in the final stages, and hope to release it [to FDA lawyers] by the end of July,” Larry Lesko, director of the Office of Clinical Pharmacology and Biopharmaceutics at the FDA, told BioArray News, Pharmacogenomics Reporter’s sister publication, as Pharmacogenomics Reporter was going to press Wednesaday afternoon. “It has been reviewed, vetted, and discussed,” he added.

Lesko said the guidance would be reviewed by FDA lawyers, who would complete their job by the end of the summer.

In March, Lesko had said the agency planned to have the document finalized for distribution by June 30 [see March 25 PGx Reporter]. “This is a target date, and there are certain things here that I have control over,” Lesko had said at the time. “But there are other issues that I do not have control over.”

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