Drug approval

Drug Approval and Labeling in the United States

A main role of the U.S. Food and Drug Administration (FDA) is to make sure that all prescription and over-the-counter drugs in the United States are safe and effective. This includes drugs that are used in cancer care.

Drug development and approval is often lengthy. There are efforts underway at the FDA to make the process more efficient. In January 2017, the FDA created the Oncology Center of Excellence (OCE). This is the first center at the FDA to focus on a group of diseases rather than specific types of drug treatments by building review teams across various FDA centers.

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