|2000D-1350 - Draft Guidance for Industry on Labeling for Combined Oral Contraceptives; Availability|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|
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.