2000D-1350 - Draft Guidance for Industry on Labeling for Combined Oral Contraceptives; Availability
FDA Comment Number : EC4
Submitter : Dr. James Shelton Date & Time: 05/06/2004 07:05:05
Organization : US Agency for International Development
Federal Government
Category :
Issue Areas/Comments

I'd like to complement you on the many improvements in this OC labeling guidance based on evidence. I especially like the strengthened warning related to smoking, and the overall simplification of the patient labeling.

However, I believe the labeling can be improved further.

See attached for specific comments.

Jim Shelton