FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: E2D(R1) POSTAPPROVAL SAFETY DATA: DEFINITIONS AND STANDARDS FOR MANAGEMENT AND REPORTING OF INDIVIDUAL CASE SAFETY REPORTS; INTERNATIONAL COUNCIL FOR HARMONISATION; GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, March 4 -- Food and Drug Administration has issued a notice called: E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports; 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 "E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports." The guidance was prepared under the auspices of the Inter...