Ready, Set, Go: ‘Unprecedented’ FDA Guidance Aims To Unburden Coronavirus Test Makers, Speed Process
The US agency issued a guidance document that significantly lowers regulation of diagnostics used specifically to fight the ongoing COVID-19 pandemic. The new policies give states far more autonomy, allow diagnostics makers to distribute products before an Emergency Use Authorization is issued by the FDA, and permits certain serological tests on the market if they adhere to proper labeling.
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The company expects testing for IgM antibodies will be useful in areas where PCR testing is not keeping up with demand.
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.
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.