Regulatory issues in clinical applications of cytokines and growth factors.

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.