Duke University's McClellan cites FDA improvements
The FDA has made significant strides in drug safety reform over the past decade, says a leading authority from Duke University.
The FDA has made significant strides in drug safety reform over the past decade, says a leading authority from Duke University.
A global company has had its third test cleared by the U.S. Food and Drug Administration which this month approved GenePOC’s Strep A assay, which provides in vitro diagnosis of Strep A infections within an hour.
The U.S. Food and Drug Administration estimates that nearly 6 million Americans have heart failure — the organ can’t keep up with their bodies’ needs.
Getting effective treatments for diseases and conditions to people as quickly as possible while guaranteeing their safety and efficacy, as well as protecting the safety of trial subjects, has always been a delicate balancing act for the U.S. Food and Drug Administration (FDA), the federal agency responsible for the safety of pharmaceuticals and medical devices, among other things.