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U.S. Department of Health and Human Services

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Summary: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

The proposed rule would amend the current regulations on submission of changes being effected (CBE-0) supplements for safety-related labeling changes to permit abbreviated new drug application (ANDA) holders to distribute revised product labeling that differs from the labeling of its reference listed drug upon submission to FDA of a CBE-0 supplement.  The proposed rule would also allow changes to the Highlights of Prescribing Information (Highlights) of drug labeling in the “Physician Labeling Rule” (PLR) format through a CBE-0 supplement.  In addition, the proposed rule would establish a Web page where FDA would post information on pending CBE-0 supplements submitted for safety-related labeling changes.

Regulatory Impact Analysis

Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (PDF - 197KB)

Federal Register: 78 FR 67985-67999, Nov. 13, 2013

Docket: FDA-2013-N-0500