title: Regulatory watch: Characterizing the US FDA's approach to promoting transformative innovation.
authors.affiliation: Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, USA.
authors.forename: Nicholas S
authors.initials: NS
authors.lastname: Downing
authors.affiliation: Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, USA.|Yale University School of Medicine, P.O. Box 208093, New Haven, Connecticut 06520, USA.
authors.forename: Harlan M
authors.initials: HM
authors.lastname: Krumholz
authors.affiliation: Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, USA.|Yale University School of Medicine, P.O. Box 208093, New Haven, Connecticut 06520, USA.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Ross
authors.affiliation: Division of Health Care Policy and Research, Mayo Clinic, Rochester, Minnesota.
authors.forename: Nilay D
authors.initials: ND
authors.lastname: Shah
mesh_terms: D000818:Animals; D017277:Drug Approval / Q000379:methods; D033161:Government Regulation; D006801:Humans; D062069:Inventions / Q000639:trends*; D014481:United States; D014486:United States Food and Drug Administration / Q000639:trends*