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.

Q: Doug, you have recently expressed optimism about the future for the Reagan-Udall Foundation. Could you explain your sense of positive movement for that initiative after four years in limbo?

Center for Drug Evaluation & Research Deputy Director Douglas Throckmorton: Since 2004, the collaborative model has been the thing that...

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