Surrogate markers, emboldened and boxed warnings, and an expanding culture of misinformation: evidence-based clinical science should guide FDA decision making about product labeling.
Shulman
Lee P
LP
Department of Obstetrics and Gynecology, Division of Reproductive Genetics, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA. lps5@cornell.edu
Bateman
Louise H
LH
Creinin
Mitchell D
MD
Cullins
Vanessa E
VE
Doyle
Lee Lee
LL
Godfrey
Emily
E
Murphy
Patricia
P
Rodriguez
Pablo
P
Spear
Scott J
SJ
Stewart
Felicia H
FH
Thomas
Michael A
MA
Westhoff
Carolyn L
CL
Worthington
Sandra
S
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
D015415:Biomarkers; D003271:Contraceptive Agents, Female