The CDER Labeling and Nomenclature Committee: Structure, Function, and Process
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0092-86 15/97 Copyright 0 1997 Drug Information Associafion Inc.
THE CDER LABELING AND NOMENCLATURE COMMITTEE: STRUCTURE, FUNCTION, AND PROCESS DANIEL L. BORING,RPH, PHD Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Sciences, Division of New Drug Chemistry 111, Division of Anti-viral Drug Products, Rockville, Maryland
The Labeling and Nomenclature committee (LNC) in the Center for Drug Evaluation and Research (CDER)at the Food and Drug Administration (FDA) is a standing technical committee overseen by the Chemistry9Manufacturing and Controls Coordinating Committee (CMCCC) in the Ofice of Pharmaceutical Sciences (OPS). The Commitreek composition, history, function, and process are presented. Key Words: Labeling and Nomenclature Committee; Proprietary names; Trademarks; Review process; Medication error prevention
INTRODUCTION
constituencies in CDER. One of CMCCC's technical committees is the Labeling and Nomenclature Committee which has been chartered to provide recommendations to reviewing divisions on labeling statements and to evaluate the acceptability of proposed proprietary and established names.
WITHIN THE FOOD and Drug Administration, the Center for Drug Evaluation and Research has developed a system of coordinating committees to provide guidance on a wide variety of technical subjects and other topics. One of these is the Chemistry, Manufacturing and Controls Coordinating Committee, which supervises several standing technical committees and working groups. The CMCCC technical committees develop and update policies and prepare guidances for these policies to be made available to regulated industry. Technical committees may also provide advisory service to internal
LNC COMPOSITION Membership on the LNC is voluntary, and all committee members have other full-time duties within the FDA. The LNC is deliberately impaneled to provide a group with wide health care and regulatory experience. Figure 1 identifies the current members and their FDA affiliations. The membership reflects a desire to incorporate representatives from key groups with labeling and trademark interests from throughout CDER. The LNC includes members from the Office of New Drug Chemistry, Office of Generic Drugs, Compendia1 Operations Staff (FDA's liaison with the United States Pharmacopeia), the Division of Drug Marketing, Advertising and Communications (DDMAC), and the Center
Presented at the DIA 32nd Annual Meeting "The Challenge of Worldwide Pharmaceutical Development in an Era of Regulatory Change: Accelerated Approval with Quality and Contained Cost," June 9-13, 1996, San Diego, California. Reprint address: Daniel L. Boring, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Sciences. Division of New Drug Chemistry 111, Division of Anti-viral Drug Products. HFD-530, 5600 Fishers Lane, Rockville, MD 20857.
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Daniel .L Boring
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FIGURE 1. Current CDER Labeling and Nomenc
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