FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ELECTRONIC SUBMISSION OF POSTMARKETING INDIVIDUAL CASE SAFETY REPORTS TO THE FOOD AND DRUG ADMINISTRATION ADVERSE EVENT MONITORING SYSTEM USING INTERNATIONAL COUNCIL OF HARMONISATION E2B(R3) DATA STANDARDS; REGIONAL DATA ELEMENTS AND IMPLEMENTATION SCHEDULE

WASHINGTON, April 6 -- Food and Drug Administration has issued a notice called: Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation E2B(R3) Data Standards; Regional Data Elements and Implementation Schedule.

The notice was published in the Federal Register on April 6 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or we) is announcing an updated data standard requirement for the submission of postmarketing individual case safety report (ICSR) submissions for human drug products, biological products, and drug- or biologic...