FDA Drug Info Rounds is a series of training videos for practicing clinical and community pharmacists. Drug Info Rounds is brought to you by pharmacists in the FDA's Center for Drug Evaluation and Research (CDER), Office of Communications (OCOMM), Division of Drug Information (DDI). Pharmacists in DDI answer hundreds of questions everyday about drug products and FDA actions. Our goal is to provide important and timely drug information to pharmacists so they can help patients make better medication decisions.
In this video, the FDA Drug Info Rounds pharmacists discuss the FDA 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.
To watch the video, please visit: Accelerated Approval Program
All videos are available at: FDA Drug Info Rounds
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