On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more
The U.S. Food and Drug Administration (FDA) just made it easier for physicians to get critically needed, but not yet approved in the U.S., treatments to some of the nation’s most critically ill patients. FDA Commissioner...more
The U.S. Food and Drug Administration (FDA) issued three final guidance documents on June 2, 2016, that address FDA's rules and regulations governing "expanded access" to investigational drugs. The expanded access process –...more
On October 30, 2015, the Food and Drug Administration (FDA) announced in the Federal Register a stay of certain portions of a September 2013 final guidance for clinical investigators, sponsors and institutional review boards...more