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Groan! -- FDA Again Delays Release of Pharmacogenomic Data Submissions Guidance

Mar 17, 2005

NEW YORK, March 17 (GenomeWeb News) - The US Food and Drug Administration has again delayed the release of its

Guidance for Industry on Pharmacogenomic Data Submissions, this time to March 22, GenomeWeb News has learned.

 

"They were originally scheduled for release on Friday, and now that's been bumped back to Tuesday," a spokesperson for the FDACenterfor Drug Evaluation and Research told GenomeWeb News. The spokesperson was careful to add that the schedule may be revised yet again.

 

In the most recent update, GenomeWeb News  ///issues/news//126179-1.html"y of Toxicology meeting in New Orleanslast week.

 

During his presentation, Goodsaid said the FDA will release the final guidance "within a week or two."

 

The document, whose approval has been delayed numerous timessince it was released as a draft in November 2003, may serve 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.

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