A federal watchdog group has announced it will conduct a broad assessment of how regulators approved certain medications, including aducanumab, the controversial drug for Alzheimer's disease (AD) that was recently approved with limited evidence of potential benefit.
The Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) announced that it will be conducting a review of the accelerated approval process. Through this approval pathway, the US Food and Drug Administration (FDA) approves drugs on the basis of signals such as biomarker data that suggest that a medication may have real-world benefit for patients
