The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the “External Controls Draft Guidance”), that...more
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) ,
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Professional Liability ,
Vaccinations ,
Virus Testing ,
World Health Organization