Most Accelerated Approval Confirmatory Studies are Turned in Late

Accelerated approval by the US Food and Drug Administration (FDA) requires drug and device manufacturers to conduct confirmatory studies to support full approval. A newly published paper in JAMA Health Forum found that over half of these studies are turned in late to the agency. These delays were more common in trials for small molecule drugs and non-oncologic therapeutics

According to Joanne S. Eglovitch, “Among the late trials, 8% were reported as delayed by the manufacturer before the due date, 27 were fulfilled one year after the deadline, three were withdrawn and 24 were completed a median of 1.8 years after the due date.”

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(Source: RAPS, April 4^th, 2023)