title: Regulatory Review of New Therapeutic Agents - FDA versus EMA, 2011-2015.
authors.affiliation: Brigham and Women's Hospital, Boston, MA.
authors.forename: Nicholas S
authors.initials: NS
authors.lastname: Downing
authors.affiliation: New York University School of Medicine, New York, NY.
authors.forename: Audrey D
authors.initials: AD
authors.lastname: Zhang
authors.affiliation: Yale School of Medicine, New Haven, CT joseph.ross@yale.edu.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Ross
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data*; D005060:Europe; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration