title: Next-generation medicines: past regulatory experience and considerations for the future.
abstract: Application of personalized medicine in drug development and regulation has been limited by similar logistical, informatics, and cultural barriers that limit use of pharmacogenetics in the clinic. An additional challenge is coordinated codevelopment of new drugs and diagnostic tests. Nevertheless, the impact of personalized medicine strategies (e.g., pharmacogenomics) is being realized. We highlight some of our experiences to date and considerations for the development of the next generation of targeted therapies.
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: M A
authors.initials: MA
authors.lastname: Pacanowski
authors.affiliation: Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: C
authors.initials: C
authors.lastname: Leptak
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: I
authors.initials: I
authors.lastname: Zineh
mesh_terms: D000818:Animals; D016503:Drug Delivery Systems; D004358:Drug Therapy / Q000639:trends*; D006801:Humans; D007880:Legislation, Drug / Q000639:trends*; D008490:Medical Informatics; D010597:Pharmacogenetics; D057285:Precision Medicine / Q000639:trends*; D014481:United States; D014486:United States Food and Drug Administration