Liability exposure and shields for vaccine developers -
As the number of COVID-19 cases continues to rise every day, efforts to develop vaccines across the globe have hit record speeds. In the U.S., the U.S. Food and Drug...more
5/28/2020
/ Center for Biologics Evaluation and Research (CBER) ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
National Institute of Health (NIH) ,
Popular ,
Professional Liability ,
Vaccinations ,
Virus Testing ,
World Health Organization
On April 2, 2019, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new regulatory framework to address the development and marketing of artificial intelligence and machine learning-based software as a...more
4/10/2019
/ Algorithms ,
Artificial Intelligence ,
Comment Period ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Facilities ,
Medical Devices ,
Popular ,
Public Comment ,
Regulatory Agenda ,
Software
FDA issued a Form FDA 483 to fifteen prominent hospitals across the United States following inspections that demonstrated failures to comply with the user facility medical device reporting requirements pursuant to 21 C.F.R....more