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Virus Resurgence Means More Need For Tests

 
• By Brian Bossetta

With COVID-19 infection rates on the rise again throughout much of the US, device manufacturers are trying to answer the need for more tests.

COVID-19 TESTING SIGN.
• Source: Alamy

When it seemed just a few months ago the US was turning the corner on the COVID-19 pandemic, the need for tests diminished as more Americans got vaccinated and a glimmer of light appeared at the end of the tunnel. But turns out that light was the oncoming Delta variant.

Average daily hospitalizations for COVID-19 – which recently topped 100,000 – are as high as they have been since the...

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• By Elizabeth Orr

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• By Marion Webb, Shubham Singh, and Nancy Pham

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More from Policy & Regulation

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By Elizabeth Orr

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.

Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By Sue Sutter

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.

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• By Brian Bossetta

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