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Reproductive Health Drugs Advisory Committee

January 24, 2007

Slides

On January 23 and 24, 2007, presentations and committee discussions addressed current issues which influence the consideration for approval of oral and non-oral (i.e., transdermal and intravaginal) hormonal contraceptive drug products.  Implantable and injectable hormone products were not discussed.  Issues for discussion included clinical trial design, expectations for efficacy and safety outcomes, and measures of acceptability of the product to the user, including cycle control.

Shelley Slaughter, M.D., PhD. (ppt) (htm)

Dr. Gerald Willett, M.D. (ppt) (htm)

Dr. Diana Petitti, M.D. (ppt) (htm)

Dr. Lisa Soule, M.D. (ppt) (htm)

Open Public Hearing Speaker

Increasing access to contraception by improving product labeling, Kelly Blanchard (ppt)

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