regulatory guidance

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.

A set of rules for IVDs will take effect in 2022, and another for medical devices will take effect in 2020.

Stakeholder input on FDA's draft Rx/Dx codevelopment guidance signals that precision medicine is actually developed differently than the agency wants it to be.

The agency is looking for information on potential food safety risks and whether new regulations are needed for genome-edited plants.

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Oxford Nanopore Technologies is looking into dual listings in London and Hong Kong, according to the South China Morning Post.

The New York Times looks into medical research funding in the US and how the grant system might not be funding the best work.

US lawmakers proposed increasing the National Science Foundation budget, including its facilities account, Science reports.

In PNAS this week: effects of gene deletions on bacterial metabolic networks, genetic responses to sea star wasting disease, and more.