regulatory guidance

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.

The FDA approved a slew of new drugs with companion and complementary tests, but the most talked about event was its decision to delay final guidance on LDTs.

The annual list includes guidelines that would clarify regulations for garnering premarket approval or clearance of devices and diagnostics, particularly next-generation sequencing tests.

The guidance may be dead, but the issues underlying the controversy aren't, according to Gibbs, who said the agency can still take enforcement action against specific tests.

According to multiple sources in Washington, DC, the FDA has been informing stakeholders in policy circles of the decision.

During an FDA-sponsored workshop last week, participants discussed ideas for a regulatory framework that can evolve with rapidly advancing technology.

Despite a negative initial reaction to the guidelines from some stakeholders, the agency wants feedback on the draft proposals and will hold another workshop to discuss them.

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The Jackson Laboratory has filed a complaint accusing Nanjing University of breeding and re-selling its mouse models, the Hartford Courant reports.

Oxford researchers are turning to virtual reality to visualize genes and regulatory elements, Phys.org says.

In Science this week: neutrophils rely on microRNA to protect against lung inflammation, and more.

China is moving forward with plans to sequence a million citizens, the Wall Street Journal reports.