2027 COVID-19 FDA Governance 
Healthcare Law Today
FEBRUARY 1, 2022
Establishes a COVID-19 Task Force to examine the origins of COVID-19 and to examine the country’s response at the Federal, state and local levels. The pilot program, which will wind down at the end of 2027, first requires the FDA to issue guidance on implementation and to provide regular reporting on projects.
SQA
FEBRUARY 15, 2023
Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. This important US document is to be reviewed for possible regulatory relevance to Annex 11. The inspection resulted in a non-compliant rating.
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Hall Render
OCTOBER 27, 2023
finds new C-suite exec at a subsidiary MONTANA COVID Map Shows Five States With ‘Substantial Increase’ in Hospital Admissions St. with historic building purchase MICHIGAN Bronson raises capital campaign goal to $4.5M
Health Law Advisor
MAY 20, 2022
Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.
Hall Render
NOVEMBER 17, 2023
Jill Biden will lead new initiative to boost federal government research into women’s health Joint Commission says acute, critical access hospitals must join safety network Lawsuit claims UnitedHealth AI wrongfully denies elderly extended care Most Rural U.S. Supreme Court won’t hear COVID vaccine case filed by N.J.
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