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The FDA Roundtable Part I: The Regulators' View of Drug Development

 
• By Ramsey Baghdadi

Three top FDA officials sat down with The RPM Report at their White Oak campus to discuss the top drug regulatory issues. On the table for discussion: drug safety, comparative effectiveness and the future of drug development.

By Ramsey Baghdadi

Is FDA using a comparative effectiveness standard for making approval decisions in certain drug classes? What role does drug safety have in the review of an investigational therapy? How many...

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