Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Guidance for Industry

Issue Date: December 15, 2025
Issued by: Center for Biologics Evaluation and Research
Topic(s): Device & Drug Safety
Status: Final

Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Guidance for Industry

Oncology Center of Excellence The guidance is intended to help clinical investigators comply with the safety reporting requirements for investigational new drug application (IND) studies and investigational device exemption (IDE) studies. Recommendations are provided in this guidance to help investigators identify safety information that needs to be reported to sponsors and institutional review boards.

Download the Guidance Document

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