regulatory guidance

An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.

The protocol could lead to greater regulatory harmonization in Europe, where every country has its own national legislation covering genetic testing.

The FDA said that pooled testing of donations using a screening test that it has licensed is a sufficient method for complying with its testing regulations.

Consent — and the right to withdraw it — underlies the EU's newly effective General Data Protection Regulation for researchers in Europe and beyond.

The agency finalized recommendations for developing and validating NGS tests, and proposed a submission process for investigational IVDs in cancer Rx trials.

Research teams and commercial firms are increasingly using genome editing to address farm animal health and welfare, from viral resistance to physical traits.

In two documents FDA discusses the development of drugs for molecular indications and investigational device exemption requirements for IVDs in drug trials.

The wide-ranging discussion with witnesses from Stanford, Johns Hopkins, and Editas Medicine touched on recent advances in research and questions of safety.

Companies are now expected to have their tests cleared by authorities for clinical use, and to bring their entire catalogs into line with the new regulations by May 2022.

The NIH is soliciting public comments on a planned update to its Genomic Data Sharing Policy that guides data management of genomic summary results.

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The New York Times and ProPublica look into the close relationship between a startup and Memorial Sloan Kettering Cancer Center.

Yahoo News reports millions of dollars are being transferred from NIH, CDC, and other programs to pay for the housing of detained undocumented immigrant children.

In Science this week: in vitro generation of human reproductive cells, and more.

Researchers gave a handful of octopuses MDMA to find that they too act more social on the drug, Gizmodo reports.