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  1. Labeling for CBER-Regulated Products

Proprietary Name Review for Biologic Products

The "proprietary name" or "trade name" of a product is the name that will:

  • be used by the applicant or other entity for the commercial distribution of the product;
  • identify the specific product in the marketplace, following approval by the Center for Biologics Evaluation and Research (CBER).

CBER's Advertising and Promotional Labeling Branch (APLB) reviews and evaluates proposed proprietary names for biological products in accordance with SOPP 8001.4: Review of Proprietary Names for CBER Regulated Products.

  • Proposed proprietary names are evaluated to avoid potential medication errors related to look-alike and sound-alike proprietary names, and avoid names that are fanciful or misleading. 
  • The review of proposed proprietary names will be evaluated under specific performance goals as outlined under PDUFA IV, Section IX: Review of Proprietary Names To Reduce Medication Errors, Subsection A: Review Performance Goals – Drug/Biological Product Proprietary Names of the PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 Through 2012.

APLB also evaluates other factors that could contribute to medication errors, such as unclear label abbreviations, acronyms, dose designations, and error prone label and packaging design. 

PDUFA Pilot Project:  PNR Concept Paper:

On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Acts of 2007, which includes the reauthorization and expansion of PDUFA IV.  As part of the reauthorization of PDUFA IV, FDA committed to certain performance goals.  In accordance with these goals, FDA agreed to develop and implement a pilot program to enable pharmaceutical firms that participate in the pilot to evaluate proposed proprietary names and to submit the data generated from those evaluations to the FDA for review.  APLB is participating in this pilot program.

The goals of the program are to minimize the use of names that are misleading or that are likely to lead to medication errors, to make FDA’s application review more efficient, and to make regulatory decisions more transparent.  Using best practices when carrying out their own proprietary name reviews and providing FDA with the data that result from those reviews may help pharmaceutical firms choose appropriate proprietary names for their products before application submission. 

At the end of the pilot, FDA will evaluate the results to determine whether the model of industry conducting reviews, submitting the results to FDA, and FDA reviewing the data is feasible and a better model than FDA conducting de novo reviews of proprietary names.  

For more information, please refer to PDUFA Pilot Project: PNR Concept Paper Oct 2008 and 10/1/09 Federal Register Notice, Pilot Program To Evaluate Proposed Proprietary Name Submissions; Procedures To Register for Participation and Submit Data.  

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