title: Surrogate markers, emboldened and boxed warnings, and an expanding culture of misinformation: evidence-based clinical science should guide FDA decision making about product labeling.
authors.affiliation: Department of Obstetrics and Gynecology, Division of Reproductive Genetics, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA. lps5@cornell.edu
authors.forename: Lee P
authors.initials: LP
authors.lastname: Shulman
authors.forename: Louise H
authors.initials: LH
authors.lastname: Bateman
authors.forename: Mitchell D
authors.initials: MD
authors.lastname: Creinin
authors.forename: Vanessa E
authors.initials: VE
authors.lastname: Cullins
authors.forename: Lee Lee
authors.initials: LL
authors.lastname: Doyle
authors.forename: Emily
authors.initials: E
authors.lastname: Godfrey
authors.forename: Patricia
authors.initials: P
authors.lastname: Murphy
authors.forename: Pablo
authors.initials: P
authors.lastname: Rodriguez
authors.forename: Scott J
authors.initials: SJ
authors.lastname: Spear
authors.forename: Felicia H
authors.initials: FH
authors.lastname: Stewart
authors.forename: Michael A
authors.initials: MA
authors.lastname: Thomas
authors.forename: Carolyn L
authors.initials: CL
authors.lastname: Westhoff
authors.forename: Sandra
authors.initials: S
authors.lastname: Worthington
mesh_terms: D015415:Biomarkers; D003142:Communication; D003271:Contraceptive Agents, Female; D004348:Drug Labeling / Q000592:standards*; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers; D003271:Contraceptive Agents, Female