FDA not doing enough to regulate antibody tests, Democrats say. 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 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.
U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md. "Be aware that not all marketed serological tests have been evaluated by the FDA," the agency wrote Monday. Commissioner of Food and Drugs Stephen Hahn speaks during the daily briefing on the novel coronavirus, which causes COVID-19, in the Brady Briefing Room of the White House, April 24, 2020.
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