Research shows that the FDA's accelerated approval program as a whole meets its expected goals

In 1992, in response to the AIDS epidemic, the FDA established an accelerated approval policy

In expedited approval, whether a drug passes or not is usually based on an alternative endpoint, which the FDA describes as "a marker, such as laboratory measurements, radiography, signs, or other measures that are thought to predict clinical benefit, but are not a measure of clinical benefit in itself

Although the accelerated approval pathway was originally used for anti-AIDS drugs, about 85% of accelerated approvals over the past 10 years have been in the field of

Fda applies the same evidentiary standards to expedited approvals as traditional approvals

Upon approval, FDA and sponsor agree on a time frame for completing the phased targets for the study, such as interim reporting, study completion, and submission of a final report

The overall effectiveness of the accelerated approval plan met expectations

A team at Amgen recently published a study in Therapeutic Innovation & Regulatory Science[1].

Questions about expedited approvals

Several products under the previous accelerated approval pathway have been approved in controversial circumstances, such as Bojian's Alzheimer's treatment drug Aduhelm (aducanumab) which has been questioned

[1] Beakes-Read, G.