Biogen Alzheimer’s Drug Approval to Get Inspector’s Probe
- Review will look at agency’s accelerated approval program
- Woodcock had sought probe amid questions about Biogen ties
The FDA headquarters in White Oak, Maryland, on July 20.
Photographer: Sarah Silbiger/Getty ImagesThis article is for subscribers only.
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.