Accelerated Approvals | Healthcare Brew

Sarepta’s gene therapy faced internal FDA doubts. Now, a teen has died

The death is heating up concerns around the FDA’s approval process.

Caroline Catherman

Dice form the expression FDA (Food and Drug Administration) approved.

FDA’s fast track process is under fire

The fast-lane approval process has raised concerns about oversight.

Caroline Catherman

Pills with arms and legs sweating as they run laps on a track.

How does the drug industry feel about new accelerated approval rules?

New rules give the FDA more power to enforce post-approval trial standards.

Shannon Young, Maia Anderson

FDA approval rubber stamp mark surrounded by pills

Fast-tracked drugs cost the US billions—and no one really knows if they work

Centers for Medicare and Medicaid Services spent $68b on 38 fast-tracked drugs.

A ringed finger presses a computer mouse, which shoots out a laser beam

A brief history of the FDA’s accelerated approvals program

The agency created the pathway in response to the HIV/AIDS epidemic.