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FDA Publishes PGx Guidance in Federal Register; Final Document Now Due Early 2005

NEW YORK, Dec. 30 (GenomeWeb News) - The US Food and Drug Administration has published in the Federal Register its draft Guidance for Industry on Pharmacogenomics Data Submissions, and now expects to release the final guidance "early next year," according to an FDA spokesperson.


The widely anticipated document, whose approval has been delayed numerous times since it was released as a draft in November 2003, is designed to encourage drug makers to use pharmacogenomics technologies in their drug-discovery efforts and submit some of their findings as a way to help the FDA broaden its knowledge of the technologies.


Published in the Federal Register on Dec. 27, the guidance may therefore be a catalyst for greater use of gene-expression and SNP-genotyping technologies, and might embolden makers of these tools to develop new versions.


As GenomeWeb News reported last month, an FDA official said the agency will issue the final guidance document before the end of the year. The document will be "out by January 2005," said  Larry Lesko, director of the FDA's Office of Clinical Pharmacology and Biopharmaceuticals.


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 at the time 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 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.