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

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.

The Scan

Gone, But Now Reconstructed SARS-CoV-2 Genomes

In a preprint, a researcher describes his recovery of viral sequences that had been removed from a common database.

Rare Heart Inflammation Warning

The Food and Drug Administration is adding a warning about links between a rare inflammatory heart condition and two SARS-CoV-2 vaccines, Reuters reports.

Sandwich Sampling

The New York Times sent tuna sandwiches for PCR analysis.

Nature Papers Describe Gut Viruses, New Format for Storing Quantitative Genomic Data, More

In Nature this week: catalog of DNA viruses of the human gut microbiome, new dense depth data dump format to store quantitative genomic data, and more.