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28 - Cancer-related symptoms: issues for consideration in drug and therapeutic biological product label claims in the United States

from Section 5 - Government and Industry Perspectives

Published online by Cambridge University Press:  05 August 2011

By
Jane A. Scott
Edited by
Charles S. Cleeland ,
Michael J. Fisch  and
Adrian J. Dunn
Jane A. Scott
Affiliation:
Macclesfield, Cheshire
Charles S. Cleeland
Affiliation:
University of Texas, M. D. Anderson Cancer Center
Michael J. Fisch
Affiliation:
University of Texas, M. D. Anderson Cancer Center
Adrian J. Dunn
Affiliation:
University of Hawaii, Manoa
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Summary

Previous chapters of this book have emphasized the importance of symptoms and symptom management in the clinical care of patients with cancer. Given the complexity of cancer and its treatment, as well as the many symptoms that could be the targets of treatment for cancer patients, it is surprising that relatively few treatments have been approved in the United States specifically for the treatment of cancer symptoms or for the treatment or prevention of symptom-producing toxicities of anticancer treatments. This is due in part to the fact that accurately documenting the effectiveness of treatments for symptoms is particularly challenging when the presence and severity of a symptom is often determined by both the cancer and the complex regimens used to treat it.

The pharmaceutical, biotechnology, and medical technology industries that develop, produce, and market products to treat or prevent cancer-related symptoms in the United States must adhere to the laws enacted by the US Congress and to the regulations established and enforced by the US Food and Drug Administration (FDA). These laws and regulations specify the research required to demonstrate the safety and efficacy of a cancer treatment. Medical product development research necessary to secure the FDA's approval to market a product in the United States requires significant investment in studies that are costly to implement and that require years to complete.

Type
Chapter
Information
Cancer Symptom Science
Measurement, Mechanisms, and Management
 , pp. 325 - 340
Publisher: Cambridge University Press
Print publication year: 2010

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