Riding In Cars With Researchers

Let's talk about FDA's emergency use authorization. Hello, I'm Dr. Jeff Kingsley and welcome to another edition of Riding in Cars with Researchers. The FDA has the ability to get products to market faster in emergency situations. It’s called the emergency use authorization, or EUA.Normally research takes 7-10 years in human clinical trials before you would ever get FDA approval.  In an era of a pandemic, this is being accelerated like I've never seen before. Sponsors are conducting what is called adaptive trial designs, where they're blending different phases of research. They are still following the normal safety protocols that we would - it's still a gated approach. But it enables faster turnaround times and faster collection of data.