Sanborn M D, Godwin H N, Pessetto J D
Department of Pharmacy, University of Kansas Medical Center, Kansas City 66103.
Am J Hosp Pharm. 1991 Dec;48(12):2659-62.
The purpose and use of the FDA's classification system for new drug products are described. Investigational new drug applications (INDs) and new drug applications (NDAs) are submitted to the FDA's Center for Drug Evaluation and Research. To establish the priority of the product in the review process, expert reviewers classify each product according to chemical type and therapeutic potential. Drug products that receive a high therapeutic rating (e.g., 1AA or 1A) are reviewed for approval more quickly than drugs that receive a lower therapeutic rating (e.g., 1B or 1C). Because this system is the only national therapeutic rating system for drug products, it has been used in legislation, in clinical evaluation of new drug products as they are approved, and in formulary decisions. However, caution is needed because the therapeutic rating assigned at the time of the product's approval may not reflect its importance relative to all agents available at a later date. The FDA classification system was designed to guide new drug products through the application process and should be used only with caution for other purposes.
描述了美国食品药品监督管理局（FDA）新药产品分类系统的目的和用途。研究性新药申请（IND）和新药申请（NDA）需提交至FDA的药品评价和研究中心。为在审评过程中确定产品的优先级，专家审评员会根据化学类型和治疗潜力对每个产品进行分类。获得高治疗评级（如1AA或1A）的药品比获得较低治疗评级（如1B或1C）的药品获批审评速度更快。由于该系统是唯一的全国性药品治疗评级系统，它已被用于立法、新药产品获批时的临床评估以及处方集决策。然而，需谨慎对待，因为产品获批时所赋予的治疗评级可能无法反映其相对于日后所有可用药物的重要性。FDA分类系统旨在指导新药产品通过申请流程，仅应谨慎用于其他目的。
