On Friday, September 13, 2013, at 1:00 - 2:30 P.M. Eastern Time, King & Spalding will host an Atlanta-based Roundtable focused on navigating the challenges of FDA’s amended regulations that further expand patient access to investigational drugs, including emergency use.  Both manufacturers that may provide investigational drugs under expanded use and healthcare providers that oversee such use are confronted with heightened expectations and misconceptions of patients and their physicians about access to investigational drugs outside of the processes and safeguards of traditional clinical trials.  This environment requires full understanding of the processes, requirements, and safeguards that will achieve appropriate access of patients to investigational drugs for treatment and that will help to anticipate and mitigate risks.  The panel will discuss insights from recent developments, including FDA’s new guidance, and practical ways to apply this knowledge.