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Home » FDASIA Fueling Upswing in De Novos, But Qualifying Can Pose Challenge
FDASIA Fueling Upswing in De Novos, But Qualifying Can Pose Challenge
More devicemakers are choosing the de novo approval pathway to get novel low-risk technologies to market quickly, thanks to changes in the way the FDA reviews these products that took effect two years ago. But knowing how to pitch a petition is key to success, an expert says.