One-Third of Pre-Approved Drugs Haven’t Completed FDA Approval Process

In 1992, the U.S. Food and Drug Administration (FDA) developed its Accelerated Approval Program. It was designed to move certain new drugs to the market faster.

The Accelerated Approval leans on a surrogate endpoint, which is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that can be used to predict clinical benefit, but isn’t by itself a measure of clinical benefit. However, use of the surrogate endpoint can shorten the time required for FDA approval.