title: Accelerating development of scientific evidence for medical products within the existing US regulatory framework.
abstract: Growing access to diverse 'real-world' data sources is enabling new approaches to close persistent evidence gaps about the optimal use of medical products in real-world practice. Here, we argue that contrary to widespread impressions, existing FDA regulations embody sufficient flexibility to accommodate the emerging tools and methods needed to achieve this goal.
authors.affiliation: US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
authors.forename: Rachel E
authors.initials: RE
authors.lastname: Sherman
authors.affiliation: US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Davies
authors.affiliation: US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
authors.forename: Melissa A
authors.initials: MA
authors.lastname: Robb
authors.affiliation: US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
authors.forename: Nina L
authors.initials: NL
authors.lastname: Hunter
authors.affiliation: US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.|Duke Clinical Research Institute, 300 W Morgan Street, Durham, North Carolina 27701, USA.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D015195:Drug Design; D004335:Drug and Narcotic Control; D006801:Humans; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*