New Age Thinking: US FDA’s Temple Sees Third Era Of Drug Development

 
• By Michael McCaughan

Robert Temple, the FDA's voice of institutional memory, believes drug regulation has quietly entered a third era: the “Age of Individualization.” Unlike the prior eras of safety and efficacy, there is no milestone legislation to set the ground rules.

Dawn-new-era
Official notes significant under-appreciated changes in areas like the assessment of drug-drug interactions, metabolic response to therapeutics, and willingness for sub-population analyses. • Source: Shutterstock

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