Surrogate markers, emboldened and boxed warnings, and an expanding culture of misinformation: evidence-based clinical science should guide FDA decision making about product labeling

Contraception. 2006 May;73(5):440-2. doi: 10.1016/j.contraception.2006.01.007. Epub 2006 Mar 13.

Authors

Lee P Shulman¹, Louise H Bateman, Mitchell D Creinin, Vanessa E Cullins, Lee Lee Doyle, Emily Godfrey, Patricia Murphy, Pablo Rodriguez, Scott J Spear, Felicia H Stewart, Michael A Thomas, Carolyn L Westhoff, Sandra Worthington

Affiliation

¹ Department of Obstetrics and Gynecology, Division of Reproductive Genetics, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA. lps5@cornell.edu

PMID: 16627028
DOI: 10.1016/j.contraception.2006.01.007

No abstract available

MeSH terms

Biomarkers
Communication
Contraceptive Agents, Female*
Drug Labeling / standards*
Evidence-Based Medicine
Female
Humans
United States
United States Food and Drug Administration

Substances

Biomarkers
Contraceptive Agents, Female