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GUIDANCE DOCUMENT

Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology January 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-5663
Issued by:
Guidance Issuing Office
Oncology Center of Excellence

This guidance provides recommendations to sponsors for the clinical development of drug and biological products intended for the prevention and treatment of chemotherapy-induced peripheral neuropathy in oncology patient populations. The guidance pertains to development programs for drugs regulated by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-5663 .

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