M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines; International Council for Harmonisation; Draft Guidance for Industry; Availability

Documents

Comments

Key Dates

Comment Period OpensJul 5, 2024

Comment Period ClosesSep 4, 2024

Type	Title	Posted	Comments	Status
Notice	M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines; International Council for Harmonisation; Guidance for Industry; Availability FR Doc: 2026-04253	Mar 4, 2026

Total Comments

2022-608

CBER

CDER

M14 General Principles on Plan, Design

and Analysis of Pharmacoepidemiological

Studies that Utilize Real-World Data

for Safety Assessment of Medicines

International Council for Harmonisation