# Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Guidance for Industry - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/investigator-responsibilities-safety-reporting-for-investigational-drugs-and-devices-guidance-for-industry/b13fb9a0-f0aa-4b42-9091-15f8390ef696 > FDA guidance document: Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Guidance for Industry. Issue date: December 15, 2025. Get complete insights and analysis. --- ## Details - Title: Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Guidance for Industry - Communication Type: Guidance Document - Product Type: drugs - Office Name: Center for Drug Evaluation and Research - Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c - Issue Date: 2025-12-15 - Comment Close Date: 2021-11-29 - Last Changed: 2025-12-15 - Docket Number: FDA-2021-D-0368 ## Related Documents - [QTc Information in Human Prescription Drug and Biological Product Labeling: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/qtc-information-in-human-prescription-drug-and-biological-product-labeling-guidance-for-industry/84e1bfb1-3a7d-4f4f-ad99-9da85ee92408) - [Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/sponsor-responsibilities-safety-reporting-requirements-and-safety-assessment-for-ind-and-bioavailabilitybioequivalence-studies-guidance-for-industry/de07fd31-d42a-4c2e-8af7-ae503e60bcbc) - [Digital Health Technologies for Remote Data Acquisition in Clinical Investigations](https://www.globalkeysolutions.net/guidances/guidance-document/digital-health-technologies-for-remote-data-acquisition-in-clinical-investigations/d03b5a1b-cf30-4bed-81a8-aa883ea62d4c)