Food and Drug Administration

Center for Drug Evaluation and Research

Advisory Committee for Reproductive Health Drugs

September 29, 2003

Hilton Hotel, the Ballrooms

620 Perry Parkway, Gaithersburg, MD

AGENDA

8:30 Call to Order and Opening Remarks Linda Giudice, M.D., Ph.D.

Introduction of Committee Chair

Conflict of Interest Statement Shalini Jain, PA-C, M.B.A. Executive Secretary, FDA

Opening Remarks Daniel Shames, M.D.

Director, Division of Reproductive and Urologic Drug Products (DRUDP)

FDA

______________________________________________________________________________

Issues relevant to the conduct of clinical trials and outcome measures for consideration of approval of drug products for the indications of induction of ovulation and pregnancy in anovulatory, infertile women and development of multiple follicles, and pregnancy in ovulatory women participating in assisted reproductive technology (ART) programs.

8:45 Ovulation Induction & Assisted David L. Keefe, M.D.

Reproductive Technology - Director, Reproductive Medicine and

Background & State of Practice Infertility

Women & Infants Hospital

Providence, RI

9:45 Questions from the Committee

10:00 Break

10:15 Gonadotropins in ART James P. Toner, M.D., Ph.D.

Director

Atlanta Center for Reproductive Medicine

Woodstock, GA

Food and Drug Administration

Center for Drug Evaluation and Research

Advisory Committee for Reproductive Health Drugs

September 29, 2003

Hilton Hotel, the Ballroom

620 Perry Parkway, Gaithersburg, MD

AGENDA (cont.)

______________________________________________________________________________

11:15 Questions from the Committee

11:30 Lunch

12:30 Human Gonadotropins – Regulatory History Shelley R. Slaughter, M.D., Ph.D.

Medical Officer Team Leader

Division of Reproductive

and Urologic Drug Products (DRUDP)

FDA

1:30 Questions from the Committee

1:45 Open Public Hearing

2:45 Break

3:00 Presentation of Questions and Committee discussion

5:00 Adjourn