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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

The history of drug regulation by the US Food and Drug Administration is usually told as two discrete steps tied to landmark legislation: the 1938 FD&C Act that required premarket safety reviews for new drugs and the 1962 amendments that additionally required substantial evidence of efficacy prior to approval.

Center for Drug Evaluation and Research deputy director for clinical science Robert Temple, however, believes FDA drug regulation has now...

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Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 
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The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

More from Pathways & Standards

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Faster HTA Reviews & Pricing Reform Could Help Fix Canada’s Drug Access Woes

 
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New EU Filings

 
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