The Food and Drug Administration (FDA) is a U.S. government agency within the Department of Health and
Human Services. Its primary role is to protect public health, by ensuring safety and effectiveness of drugs,
vaccines, medical devices and food products. There are rigorous steps that may take years, and all these
steps must be completed before a drug can be approved. The FDA has made some lifesaving investigational
drug therapies available sooner than usual by offering an expedited drug approval process, known as “Fast
Track”.
I. Discuss the process and regulations of Fast Track.
II. Identify which medical conditions warrant the use of “Fast Track” drugs

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