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Release of FDA Pharmacogenomic Guidelines Imminent: FDA Official

TORONTO, Oct. 30 (GenomeWeb 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.


"It's done," said Lesko after an invited session on pharmacogenetics held at the 54th annual American Society of Human Genetics meeting, held here last week. "It's been done for about four weeks. There is no scientific reason it's not going out," Lesko added. He said he could not provide an exact date for the guidance's release.


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.

The new due-date marks at least the third time the much-awaited guidance has been delayed. According to Pharmacogenomics Reporter, a GenomeWeb News sister publication, Lesko said in June that the guidance will be completed by the end of the summer. The regulatory agency had originally planned for it to release by June 30.

"We're in the final stages, and hope to release it [to FDA lawyers] by the end of July," Lesko said in June. "It has been reviewed, vetted, and discussed."

Lesko said the guidance would be reviewed by FDA lawyers, who would complete their job by the end of the summer. The draft guidance was released to industry in November 2003. Read the draft guidance hereRead about big pharmas' response to the draft here.


In March, Lesko had said the agency planned to have the document finalized for distribution by June 30. "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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