Not Renewing COVID-19 Public Health Emergency Could Have Serious Consequences: Lobby Group
Tests may need to be pulled from the shelves if the COVID-19 Public Health Emergency isn’t renewed before it would expire this month, device lobby group AdvaMed claims. But HHS has indicated plans to renew the order.
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Experts At US House Subcommittee Criticize FDA’s Initial Lack Of Serology Testing Oversight
The FDA’s initial lack of oversight of the tests shows why it is important for the agency to continue its public health responsibility in ensuring safe and effective products get to market, a panel of experts told lawmakers.
FDA Yanks Potentially Faulty COVID-19 Antibody Tests – And More May Be On The Chopping Block
After criticism it was being too lax in overseeing COVID-19 antibody tests coming to market, the US agency issued an updated guidance earlier this month tightening regulations. As a result, it has now pulled more than two dozen tests that don’t meet its standards – and more are expected to follow.
Faulty CDC COVID-19 Assays Leave Only 12 US Jurisdictions With Testing Ability, CDC Director Says
Only 12 US jurisdictions currently have sound COVID-19 virus assays from the Centers for Disease Control and Prevention to test suspected virus cases, CDC director Robert Redfield told a House panel looking at virus preparedness on Wednesday – but a better batch is coming, he said. Other questions raised at the congressional hearing was how long an infected person stays infected, whether COVID-19 can be picked up from inanimate surfaces, and related queries.