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Few Billion More

Bloomberg reports the budget of Operation Warp Speed is actually $18 billion, higher than the number typically cited.

The New York Times reports that a series of emails show how Department of Health and Human Services officials sought to silence the Centers for Disease Control and Prevention.

Caputo on Leave

Michael Caputo, the top Department of Health and Human Service spokesperson, is taking a leave of absence, CNN says.

Review Sought

Politico reports that political appointees are interfering with what appears in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Reports.

The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate.

The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.

CNN reports the change in the US Centers for Disease Control and Prevention's coronavirus testing guidelines was in response to administration pressure.

Shift in Regulation

An announcement last week says laboratory-developed tests do not need to undergo premarket review by FDA.

While observers are still sorting out the implications of the surprise announcement, it will likely limit the agency's role in regulating LDTs.

The action will immediately allow labs to offer SARS-CoV-2 LDTs without requiring EUA, and make it voluntary for labs to take LDTs through FDA premarket review.

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Novavax has begun a phase III trial of its SARS-CoV-2 vaccine, according to the New York Times.

Vox reports that the Trump Administration may limit student visas for individuals from some countries to two years.

The governor of New York says the state will conduct its own review of any SARS-CoV-2 vaccine, NPR reports.

This week in Science: Neanderthal Y chromosomes replaced by Homo sapiens Y chromosomes, and more.