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.

COVID-19 98

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.

US Department of Health and Human Services 40

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.

COVID-19 Vaccine 52

COVID-19 Vaccine FDA Pharmaceutical Industry COVID-19 52

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 FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.

FDA 52

FDA COVID-19 Compliance Governance 52

Hall Render

SEPTEMBER 20, 2024

Federal Grant to Study Eye Disease UAMS Study to Address Maternal, Infant Deaths with $2.4M headcount among top 10 biopharma employers shrinks New Mass. headcount among top 10 biopharma employers shrinks New Mass. Mary’s Hospital helps high-risk babies Reasons behind 3 recent CON denials St.

US Department of Health and Human Services 40

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

Hall Render

AUGUST 16, 2024

Check list of latest federal quality ratings Obesity rates are skyrocketing in NJ post-COVID. Why Kaiser’s Risant Health set up base in DC MedStar Health Kids Mobile Medical Clinic Debuts New Look and Celebrates a $1.1 What’s causing it?

US Department of Health and Human Services 40

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

Hall Render

AUGUST 16, 2024

Check list of latest federal quality ratings Obesity rates are skyrocketing in NJ post-COVID. Why Kaiser’s Risant Health set up base in DC MedStar Health Kids Mobile Medical Clinic Debuts New Look and Celebrates a $1.1 What’s causing it?

US Department of Health and Human Services 40

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