title: Regulatory science as a bridge between science and society.
abstract: Development of innovative drugs has recently become more difficult. The case of rosiglitazone shows the extreme difficulty of making the regulatory decision that will best balance the benefits and risks of a drug. There is a high expectation that regulatory science (RS) can improve the situation. However, without user understanding of its basic characteristics, RS will not deliver what is expected.
authors.affiliation: Pharmaceuticals and Medical Devices Agency, Tokyo, Japan. tominagatoshiyoshi@pmda.go.jp
authors.forename: T
authors.initials: T
authors.lastname: Tominaga
authors.forename: Y
authors.initials: Y
authors.lastname: Asahina
authors.forename: Y
authors.initials: Y
authors.lastname: Uyama
authors.forename: T
authors.initials: T
authors.lastname: Kondo
mesh_terms: D003627:Data Interpretation, Statistical; D016208:Databases, Factual; D003657:Decision Making; D017277:Drug Approval; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000639:trends; D005060:Europe; D006077:Government Agencies / Q000331:legislation & jurisprudence*; D006801:Humans; D010601:Pharmacology, Clinical / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration