Biologics Regulations; Reporting Changes to an Approved Application; Open Public Meeting

The Food and Drug Administration (FDA) is announcing an open public meeting to discuss issues related to the agency's final rule entitled, ``Changes to an Approved Application'' announced previously in the Federal Register. The final rule amended the biologics regulations for reporting changes to an approved application reviewed in the Center for Biologics Evaluation and Research (CBER) and the corresponding drug regulations for reporting changes to an approved application for specified biotechnology products reviewed in the Center for Drug Evaluation and Research (CDER). The purpose of the meeting is to present the regulatory procedures set forth in the final rule and to solicit public comment on a portion of the final rule that addresses the use of a ``comparability protocol.''