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Pharmacogenomics Data Submission Guidance Due By End of Year, Says FDA s Lesko

NEW YORK, Nov. 12 (GenomeWeb News) - The US Food and Drug Administration will issue the final guidance document for pharmacogenomic data submissions before the end of the year, according to Larry Lesko, director of the FDA's Office of Clinical Pharmacology and Biopharmaceuticals yesterday at Scientific American's Targeted Medicine conference.

 

The document will be "out by January 2005," Lesko said during a lunchtime keynote address titled "How is the FDA Preparing for the Increasing Application of Pharmacogenomics in Drug Development?"

 

Organizational difficulties related to the recent presidential election and the requirement that "three people have to sign off" on the guidance in each of the FDA's related centers contributed to the delay, Lesko said.

 

The guidance will appear on a special FDA website upon release, along with a companion Manual of Policies and Procedures and "frequently asked questions" documents, said Lesko. He did not disclose the website address.

 

Following an invited session on pharmacogenetics held Oct. 29 at the 54th annual American Society of Human Genetics meeting in Toronto, Lesko told GenomeWeb News that the guideline's release was not delayed because of revisions to the document itself. "It's been done for about four weeks," said Lesko. "There is no scientific reason it's not going out."   He said then that the guidance would be issued as soon as final legal and other reviews of the document were completed.

 

The Jan. 1 due date follows a string of at least three previous, revised deadlines. Pharmacogenomics Reporter, a GenomeWeb News sister publication, reported in June that Lesko expected the completed guidance by the end of the summer. The regulatory agency had originally planned 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."

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