Skip to main content
Premium Trial:

Request an Annual Quote

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

Expanded Genetic Testing Uncovers Hereditary Cancer Risk in Significant Subset of Cancer Patients

In Genome Medicine, researchers found pathogenic or likely pathogenic hereditary cancer risk variants in close to 17 percent of the 17,523 patients profiled with expanded germline genetic testing.

Mitochondrial Replacement Therapy Embryos Appear Largely Normal in Single-Cell 'Omics Analyses

Embryos produced with spindle transfer-based mitochondrial replacement had delayed demethylation, but typical aneuploidy and transcriptome features in a PLOS Biology study.

Cancer Patients Report Quality of Life Benefits for Immune Checkpoint Inhibitors

Immune checkpoint inhibitor immunotherapy was linked in JAMA Network Open to enhanced quality of life compared to other treatment types in cancer patients.

Researchers Compare WGS, Exome Sequencing-Based Mendelian Disease Diagnosis

Investigators find a diagnostic edge for whole-genome sequencing, while highlighting the cost advantages and improving diagnostic rate of exome sequencing in EJHG.