title: Precision medicine and the changing role of regulatory agencies.
abstract: The growth of precision medicine presents challenges for the regulators of medicines, related to aspects that include the basis of evidence generation, patient involvement in the regulatory process, cost of new medicines and the need for new regulatory models. It also raises questions about the tolerance of risk, especially with early interventions for life-threatening diseases.
authors.affiliation: Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool L69 3BX, UK.
authors.forename: Alasdair
authors.initials: A
authors.lastname: Breckenridge
authors.affiliation: European Medicines Agency, London E14 5EU, UK.
authors.forename: Hans-Georg
authors.initials: HG
authors.lastname: Eichler
authors.affiliation: US Food and Drug Administration, Silver Spring, Maryland 20993, USA.
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Jarow
mesh_terms: D033161:Government Regulation; D006801:Humans; D010358:Patient Participation; D057285:Precision Medicine / Q000191:economics; D018570:Risk Assessment