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CDER's Novel Approvals In 2018 Show Remarkable Review Consistency

 
• By Bridget Silverman

Years of regulatory fine-tuning culminated in record low average time to approval of 9.9 months for novel agents at US FDA’s drug center.

Red Approved Stamp with Wooden handle Rubber Stamper Isolated on White Background.

The 2018 class of novel approvals for the US FDA’s Center for Drug Evaluation and Research is notable not only for its record-setting size, but also for the efficiency and speed of its reviews, which produced another record-setting number: at 9.9 months, the average time from submission to approval in the CDER class of 2018 is the shortest of the modern era.

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