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Biogen Alzheimer’s Drug Approval to Get Inspector’s Probe

Aug. 4, 2021, 5:35 PM

A federal watchdog said it will examine U.S. drug regulators’ use of an approval process intended to grant speedier access to experimental medicines.

The Food and Drug Administration’s accelerated approval pathway is meant to get potentially promising treatments to market faster by allowing use of therapies while drugmakers continue to study them. Its backers say it helps quickly address unmet medical needs.

Regulators have granted such clearances to a range of medications, including Biogen Inc. Alzheimer’s therapy Aduhelm. But some critics of the process say the FDA has used the pathway too often and that drugmakers sometimes fail to complete ...