Docket Management
Docket: 80N-0280 - Over-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol 9; Required Labeling
Comment Number: EC -123

Accepted - Volume 14

Comment Record
Commentor Dr. cathy conway johnson Date/Time 2003-03-05 17:40:04
Organization MPRES
Category Health Professional

Comments for FDA General
Questions
1. General Comments The study population for nonoxynol 9 was commercial sex workers in Africa and Thailand. Can the findings be reasonably extrapolated for the general US population? I would expect the warning label to reflect the source data.




EC -123