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Role of the US Food and Drug Administration in Cancer Drug Development

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Principles of Anticancer Drug Development

Part of the book series: Cancer Drug Discovery and Development ((CDD&D))

Abstract

The US Food and Drug Administration (FDA) oversees the development of agents to diagnose, cure, mitigate, treat, or prevent cancer. The FDA’s mission statement is “The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health” [1]. The FDA accomplishes its mission through meetings with individual investigators and sponsors, review of investigational new drug (IND) and new drug applications (NDA), facilities inspections, approval of marketing and licensing applications, and the administration of grant programs.

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Author information

Authors and Affiliations

  1. Division of Hematology Products, Office of Oncology Drug Products (OODP), Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, 20993-0002, USA

    Ann T. Farrell

Authors
  1. Ann T. Farrell
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  2. Ramzi N. Dagher
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  3. Richard Pazdur
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Corresponding author

Correspondence to Ann T. Farrell .

Editor information

Editors and Affiliations

  1. Dept. Biostatistics, Bioinformatics &, Epidemiology, Medical University of South Carolina, Jonathan Lucas St. 86, Charleston, 29466, South Carolina, USA

    Elizabeth Garrett-Mayer

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Farrell, A.T., Dagher, R.N., Pazdur, R. (2011). Role of the US Food and Drug Administration in Cancer Drug Development. In: Garrett-Mayer, E. (eds) Principles of Anticancer Drug Development. Cancer Drug Discovery and Development. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-7358-0_12

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  • DOI: https://doi.org/10.1007/978-1-4419-7358-0_12

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