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.
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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.
The US FDA is partnering with industry stakeholders and advocacy groups to investigate the long-term effectiveness of COVID-19 tests. The announcement follows recent moves by the agency to pull a slew of antibody tests from the market due to a high rate of false negatives and criticism from stakeholders, including lawmakers.
As the number of emergency use applications (EUAs) for COVID-19 tests have mushroomed, the director of the US FDA’s in vitro diagnostics division says he’s directed his office to ensure all sponsors are assigned an agency liaison within two weeks of receiving a completed application. And if an officer isn’t assigned, Timothy Stenzel told sponsors to personally reach out to him so he can intervene on their behalf.