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.
Keywords: investigational drug application (IND), post-marketing, new drug application (NDA), Clinical trials, Drug development
Current Cancer Therapy Reviews
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:
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.
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Cite this article as:
Dagher N. Ramzi and Pazdur Richard, The Role of FDA in the Regulation of Anti-Cancer Drugs, Current Cancer Therapy Reviews 2006; 2 (4) . https://dx.doi.org/10.2174/157339406778699196
DOI https://dx.doi.org/10.2174/157339406778699196 |
Print ISSN 1573-3947 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-6301 |
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