Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry; Availability | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2021-D-0368

Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry; Availability

Documents

Comments

Description

Open

Key Dates

Comment Period OpensSep 30, 2021

Comment Period ClosesNov 30, 2021

Documents

Type	Title	Posted	Comments	Status
Notice	Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards; Availability FR Doc: 2025-22869	Dec 16, 2025

Comment Statistics

Total Comments

Keywords

2019-556

CDER

Draft Guidance

Investigator Responsibilities--Safety Reporting

for Investigational Drugs and Devices;

Draft Guidance for Industry; Availability

Open

Data from Regulations.gov