Biologics comparability protocol approval could lessen manufacturing changes reporting -- CBER's Zoon.

Executive Summary

BIOLOGICS "COMPARABILITY PROTOCOL" COULD LESSEN REPORTING REQUIREMENTS, under the final rule on changes to an approved application, Center for Biologics Evaluation & Research Director Kathryn Zoon told a Food & Drug Law Institute conference on July 23. The comparability protocol "will allow the manufacturer to reduce the level of risk by putting it in a lower category based on protocol defining how you are going to do the comparison study." Zoon said that "essentially a substantial risk item moves to a moderate risk, and likewise a moderate risk might move down to an annual report-type notification, depending on its comparability protocol."