2004D-0555 Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
FDA Comment Number : EC1
Submitter : Dr. James Trussell Date & Time: 11/17/2005 02:11:52
Organization : Princeton University
Category : Academia
Issue Areas/Comments
GENERAL
GENERAL
The pregnancy rate table on paged 11 and 24 is based on the 1998 edition of Contraceptive Technology. That table is now out of date, having been superceded by Table 31-1 in the 2004 edition of Contraceptive Technology [Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Nelson A, Cates W, Guest F, Kowal D. Contraceptive Technology: Eighteenth Revised Edition. New York NY: Ardent Media, 2004.]

The table was also published as part of a paper in a perr-reviewed journal [Trussell J. Contraceptive failure in the United States. Contraception 2004;70(2):89-96.]

The table is attached.
2004D-0555-EC1-Attach-1.PDF