Title: The Role of FDA in the Regulation of Anti-Cancer Drugs
VOLUME: 2 ISSUE: 4
Author(s):Ramzi N. Dagher and Richard Pazdur
Affiliation:Division of Drug Oncology Products, Office of Oncology Drug Products, USFDA, Room 2108, Building 22, White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
Keywords:investigational drug application (IND), post-marketing, new drug application (NDA), Clinical trials, Drug development
Abstract: 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.
