Health
Trump bans FDA review of coronavirus tests
The Trump administration has a coronavirus test developed by individual laboratories, Food and Drug Administration (FDA) Review, administration It was announced on Wednesday.
Staff Told Politico And the Washington Post The decision was made after the Health and Human Services (HHS) decided that the FDA was not authorized to regulate laboratory-developed tests for all conditions, including COVID-19, he said.
FDA officials are reportedly opposed to this move because some tests were found to be flawed, but supporters have hampered the FDA’s approval process for its ability to rapidly develop and release tests. I argue that
Policy changes have heightened tensions between HHS Secretary Alex Hazard and FDA Commissioner Stephen Hahn, the department said. Hahn alleges that an emergency such as a pandemic empowers the FDA to regulate laboratory tests.
HHS was also concerned that the FDA would require an emergency license for a test developed in the laboratory in February. The agency has requested approval in other public health emergencies, including the H1N1 pandemic in 2009 and the Zika epidemic in 2015 and 2016.
Agency allowed 35 Emergency use permit For testing developed in this week’s lab.
Although lab-developed tests are widely used, most testing in the United States is done by the device manufacturer and requires the approval of the FDA to create a test.
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