Oncology drug development is an increasingly complex effort involving multiple stakeholders on a global scale. This review summarizes the role of the United States Food and Drug Administration (USFDA) and its office of oncology drugs in the regulation of anticancer drug therapies. The regulatory history of FDAs mission will be summarized. The FDAs role from first-in-human dose finding studies to trials designed to evaluate efficacy, as well as post-marketing considerations will be outlined. During this entire process, the FDA is committed to productive interactions with all its stakeholders, including the public, the pharmaceutical industry, academia, other government agencies and patient advocacy groups.
Keywords: investigational drug application (IND), post-marketing, new drug application (NDA), Clinical trials, Drug development
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