Swordsmyth
03-06-2020, 02:27 AM
The Trump administration has rolled back a Food And Drug Administration rule instituted by President Barack Obama that has stalled coronavirus testing at the state level.
The rule (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-policy-help-expedite-availability-diagnostics) in question previously required state-run laboratories to only run medical tests pre-approved by the F.D.A.
Commissioner Stephen Hahn first addressed the testing problem on Saturday by issuing new guidance (https://www.fda.gov/media/135659/download) that would allow the state labs to conduct not-yet-approved coronavirus (https://dailycaller.com/2020/03/03/coronavirus-vaccine-timeline-world-health-organization/) testing on patients in response to the public health emergency. In return for skirting the Obama-era regulation, laboratories must apply for an F.D.A. review of the new test, document the test’s accuracy and notify the F.D.A. of the test’s validity prior to F.D.A. completing the approval process.
More at: https://dailycaller.com/2020/03/04/trump-administration-obama-fda-rule-coronavirus-testing/
The rule (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-policy-help-expedite-availability-diagnostics) in question previously required state-run laboratories to only run medical tests pre-approved by the F.D.A.
Commissioner Stephen Hahn first addressed the testing problem on Saturday by issuing new guidance (https://www.fda.gov/media/135659/download) that would allow the state labs to conduct not-yet-approved coronavirus (https://dailycaller.com/2020/03/03/coronavirus-vaccine-timeline-world-health-organization/) testing on patients in response to the public health emergency. In return for skirting the Obama-era regulation, laboratories must apply for an F.D.A. review of the new test, document the test’s accuracy and notify the F.D.A. of the test’s validity prior to F.D.A. completing the approval process.
More at: https://dailycaller.com/2020/03/04/trump-administration-obama-fda-rule-coronavirus-testing/