Description
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.
Scope & Applicability
Product Classes
2The drug or biological product being developed to treat or prevent CIPN.
Requires analytical comparability per ICH Q5E
Stakeholders
2Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
2Used when trials enroll participants with multiple tumor types.
The status of the guidance document.
Identified Hazards
Hazards
2Treatments that commonly cause peripheral neuropathy.
Concern that CIPN-mitigating drugs may potentially promote tumor growth.; A potential risk of the CIPN drug interfering with cancer treatment.
Related CFR Sections (1)
- 21CFR50.25§ 50.25 Elements of informed consent.
(a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject:Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-03-26
Institutional Review Board (IRB)
New York State Psychiatric Institute IRB
- 2023-06-06
Investigational Device Exemptions (Clinical Investigator)
Mobeen Mazhar, M.D.
See Also (8)
- CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
- Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects: Guidance for Industry and FDA Staff (Status: Final)
- Pharmacogenomic Data Submissions: Guidance for Industry (Status: Final)
- Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs: Guidance for Industry and FDA Staff (Status: Final)
- Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials: Guidance for Sponsors, Clinical Investigators, and IRBs (Status: Final)
- Considerations for Allogeneic Pancreatic Islet Cell Products: Guidance for Industry (Status: Final)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- Cellular Therapy for Cardiac Disease: Guidance for Industry (Status: Final)