Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology." Chemotherapy-induced peripheral neuropathy (CIPN), a painful, disabling, and potentially irreversible condition commonly affecting patients receiving neurotoxic chemotherapies, could diminish survival by potentially increasing chemotherapy treatment interruptions, dose reductions, and discontinuations. This guidance provides recommendations to sponsors for the clinical development of drug and biological products intended for the prevention and treatment of CIPN in oncology patient populations.
Abstract as published in the Federal Register.
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