FDA Drug Info Rounds, July 2012: Accelerated Approval Program

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious diseases, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker that is used in clinical trials as an indirect or substitute measurement that represents a clinically meaningful outcome. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.
Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.
For more information, please see our website:
www.fda.gov/For... [vpdrugs]