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Guidance Documents/Guidance-Document/Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Guidance for Industry

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

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

December 15, 2025

December 15, 2025

Center for Drug Evaluation and Research

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