A Regulator’s Perspective For 2013: FDA’s Temple Discusses FDASIA, Caronia, and Breakthrough Development

FDA’s dean of drug development Robert Temple offered his perspective on a number of different issues facing the agency and the drug industry at The RPM Report’s FDA/CMS Summit, including the impact of FDASIA, the Caronia off-label promotion ruling, and new approval pathways. Below is an edited transcript of his comments.