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The funding package earmarks billions for the Public Health and Social Services Emergency Fund and Biomedical Advanced Research and Development Authority.

The forum will gather information on issues surrounding SARS-CoV-2 testing and diagnostics from federal officials and the private sector.

Issued last week, the guidance said insurers were not required to reimburse such testing, which could impact coverage in schools, workplaces, and other settings.

The experts said that antibody testing cannot indicate an individual's immunity or help with return-to-work schemes but have use for public health agencies.

The recommendations are intended to improve testing capacity for SARS-CoV-2 by providing ways to combat testing supply shortages and expanding funding, among other steps.

The bills would award grants to help public health laboratories purchase high-throughput instruments and to help support diagnostic testing outside of the lab setting.

The agency will now require commercial antibody test manufacturers to meet certain sensitivity and specificity thresholds.

The "roadmap" to getting the economy rolling again calls for the rapid scaling up of testing and a pipeline to develop tests, among other things.

Two US representatives have requested details about the accuracy of the various SARS-CoV-2 diagnostics being used in response to the ongoing pandemic.

In a letter, the Trump administration has asked hospitals to report their SARS-CoV-2 testing data every day to HHS.

If the bill passes in its current form, PAMA reporting would be delayed until January 2022 and rate cuts scheduled for 2021 would be put off to 2022.

The VITAL Act strikes a counterpoint to another bipartisan-backed bill, called VALID, that would give FDA oversight responsibilities over all clinical tests, including LDTs.

The sponsors of the VALID Act say it's time to modernize outdated diagnostic regulations slowing down test access during a public health crisis.  

A pathologists' group has pointed out that the bill covers only EUA tests, and patients receiving tests with pending regulatory status may receive surprise bills.

In announcing a national emergency on Friday, Trump paraded out executives from the private sector as the administration tries to increase testing capacity

Under the NYSDOH's approach, labs need to provide validation data within 15 days of starting to test instead of having to pursue an EUA with the FDA.

The funding, part of a larger initiative by Genome Canada, will support two studies in British Columbia that will evaluate genomics in healthcare.

Aiming to improve patient access to critical drugs and tests, a group of legislators have started a caucus to shore up bipartisan support for personalized medicine.

The groups have written draft recommendations and are now asking for public comment from pathologists and other stakeholders.

The proposed Medicines and Medical Devices Bill updates the framework for regulating IVDs following the UK's exit from the EU.

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