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FDA Reopens Comment Period on Generic Drug Labeling Rule

March 16, 2015

The U.S. Food and Drug Administration (FDA) reopened a comment period for its proposed rule “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.” The proposed rule, if finalized, would enable abbreviated new drug application (ANDA) holders for generic drugs to update product labeling promptly to reflect newly acquired safety-related information, regardless of whether the revised labeling differs from that of the corresponding reference listed drug (RLD or brand drug) upon submission of a changes being effective (CBE-o) supplement to FDA. A public meeting, scheduled on March 27, 2015, has also been set to accommodate stakeholders’ comments on the “proposed rule or any alternative proposals intended to improve communication of important newly acquired drug safety information to health care professionals and the public.”

Comments will be accepted after the public meeting until April 27, 2015.