title: Perspectives in regulatory science: translational and clinical pharmacology.
abstract: This paper focuses on the role of clinical and translational pharmacology in the drug development and the regulatory process. Contemporary regulatory issues faced by FDA's Office of Clinical Pharmacology (OCP) in fulfilling its mission to advance the science of drug response and translate patient diversity into optimal drug therapy are discussed. Specifically current focus of the following key aspects of the drug development and regulatory science processes are discussed: the OCP vision and mission, two key OCP initiatives (i.e. guidance modernization, labeling and health communications), and translational and clinical pharmacology related regulatory science issues in (i.e. uncertainty, breakthrough therapies, individualization).
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States.
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Grillo
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States. Electronic address: ShiewMei.Huang@fda.hhs.gov.
authors.forename: Shiew Mei
authors.initials: SM
authors.lastname: Huang
mesh_terms: D055808:Drug Discovery / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug; D010601:Pharmacology, Clinical / Q000331:legislation & jurisprudence*; D057170:Translational Research, Biomedical / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration