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

 
• By Ramsey Baghdadi

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.

Ramsey Baghdadi, The RPM Report: FDA has just gone through a major legislative cycle, with the fifth reauthorization of the prescription drug user fee act with the omnibus bill called FDA Safety & Innovation Act. How would you assess the impact of FDASIA?

Robert Temple, CDER Deputy Director for Clinical Science: A good question for everybody is: what did FDASIA give us that we didn’t have? If you go back and read what’s...

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