Weiss K D, Siegel J P, Gerrard T L
Office of Therapeutics, Center for Biologics Evaluation and Review, Food and Drug Administration, Bethesda, MD 20892.
Prog Growth Factor Res. 1994;5(2):213-22. doi: 10.1016/0955-2235(94)90006-x.
This article describes the drug approval process at the Center for Biologics Evaluation and Research (CBER), FDA, for cytokines and growth factors that would be licensed for clinical use in the U.S.A. CBER is responsible for setting policy, providing guidance to industry and to academic investigators as they develop and evaluate these new products, and for recommendations about the approvability of license applications. Product development generally parallels clinical development, and the expectations at each stage of the IND (Investigational New Drug) process are discussed. FDA involvement continues beyond licensure to the post marketing phase. The goal is to assure that new cytokines and growth factors are safe and effective and available in a timely manner.
本文介绍了美国食品药品监督管理局（FDA）生物制品评估和研究中心（CBER）对将在美国获得临床使用许可的细胞因子和生长因子的药物批准过程。CBER负责制定政策，在行业和学术研究人员开发和评估这些新产品时提供指导，并就许可申请的可批准性提出建议。产品开发通常与临床开发并行，并讨论了IND（研究性新药）过程每个阶段的期望。FDA的参与在获得许可后持续到上市后阶段。目标是确保新的细胞因子和生长因子安全有效且能及时供应。
