FDA Takes Steps To Improve Expanded Access, Clarify Right To Try Pathway

FDA is taking steps to both improve its existing Expanded Access Program and simultaneously implement the recently enacted Right to Try law, which agency commissioner Scott Gottlieb stressed Thursday (Nov. 8) are separate distinct pathways by which certain patients can get experimental drugs. Gottlieb on Thursday announced the agency's plans to establish an agency-wide Patient Affairs Staff and Health Care Provider Affairs Program that will serve as a “home base” to help patients and physicians navigate the Expanded Access process,...