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.

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COVID-19 FDA Public Health Health Services Administration 98

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. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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US Department of Health and Human Services FDA COVID-19 World Health 40

Dot Compliance

FEBRUARY 1, 2022

The race to develop a COVID-19 vaccine highlighted the power of artificial intelligence (AI) and machine learning (ML) as Johnson & Johnson, Moderna and Pfizer employed these technologies to swiftly get their vaccines to market. The next evolution is for companies to implement Industry 4.0 Data in the regulatory spotlight.

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FDA COVID-19 Vaccine Pharmaceutical Industry COVID-19 52

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

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US Department of Health and Human Services Nurses Nursing Homes Hospitals 40

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 FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.

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FDA COVID-19 Compliance Governance 52

Hall Render

NOVEMBER 17, 2023

Supreme Court won’t hear COVID vaccine case filed by N.J. Supreme Court won’t hear COVID vaccine case filed by N.J. Grifols gets FDA approval for new facility in Clayton Invitae pledged $115M, 374-job investment in North Carolina. quarterly loss; CEO outlines expansion plans Temple’s Fox Chase Cancer Center awarded $13.3

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Nursing Homes Nurses Hospitals Doctors 40

Hall Render

JANUARY 12, 2024

Delaware continues to see rise in COVID cases, hospitalizations after pre-holiday surge Enovis closes $900M deal for orthopedics co. to settle improper billing allegations COVID-19 variant JN.1 to settle improper billing allegations COVID-19 variant JN.1 to settle improper billing allegations COVID-19 variant JN.1

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Nursing Homes US Department of Health and Human Services COVID-19 Nurses 40