Regulatory Innovation: A Dialogue (Part II)

Center for Drug Evaluation & Research Deputy Director Douglas Throckmorton and AstraZeneca R&D President Martin Mackay took part in a moderated discussion of new initiatives and ideas for drug regulation during The RPM Report’s FDA/CMS Summit in Washington DC in December 2011. The first part of the dialogue focusing on drug review activities was previously published; this second section addresses post-market activities and the impact of data from different types of clinical experience on FDA regulation. The conversation was transcribed by The RPM Report and lightly edited for clarity.