The right-to-try bills passed by Congress would remove FDA’s expanded access mandate and leave patients at greater risk, said Arthur Caplan, the Drs. William F. and Virginia Connolly Mitty Professor and founding director of the Division of Medical Ethics at the New York University School of Medicine.
A group of melanoma experts, joined by three advocacy groups focused on melanoma, has engaged FDA in a public discussion of the challenges of developing new drugs in the refractory setting and the role crossover can play in such trials.
