FOOD AND DRUG ADMINISTRATION ISSUES 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

WASHINGTON, March 4 -- Food and Drug Administration has issued a notice called: 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.

The notice was published in the Federal Register on March 4 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety A...