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You are here: Home / FDA not doing enough to regulate antibody tests, Democrats say

FDA not doing enough to regulate antibody tests, Democrats say

The Food and Drug Administration is not doing enough to review and police the wave of new coronavirus antibody tests on the market that could determine how to reopen the economy, House Democrats said on Friday. Their concerns are detailed in a new Democratic staff memo from the House Oversight Committee to members about the preliminary findings in the panel’s antibody testing investigation. The letter warns that the widespread use of the antibody tests without more regulation could jeopardize Americans’ health . MORE:Could a simple blood test for COVID-19 antibodies help reopen the economy? The agency began allowing developers to sell their products without prior review in March, as long as the companies promise to validate their tests, notify the FDA that it has done so and market them with the appropriate disclaimers. “We provide flexibility,” FDA Administrator Stephen Hahn said at the White House briefing on Friday. “We have told manufacturers that in order to market in the U.S. they have to validate their test. … They have to let those people know … that the tests were not authorized by the FDA.” Tune into ABC at 1 p.m. ET and ABC News Live at 4 p.m. ET every… Read full this story

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  • Retesting of Symptomatic Patients With No COVID Antibodies Needed, Indian Health Ministry Says
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  • Coronavirus immunity may only last a few months: Study finds a quarter of patients have LOST antibodies and 4% of England has them - DOWN from 6% - but the body's other defences could fight off re-infections
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