Background Package

Advisory Committee Meeting

Human Gonadotropins: A Regulatory Perspective

 

Table of Contents

 

Tab 1                    Introduction………………………………......................   1.0

 

Tab 2                    Definitions……………………………………………… 2.0

 

                             

Tab 3                    Background Information……………………………….. 3.0

 

Tab 4                    Bibliography

 

                              Misra D. The Women’s Health Data Book: A profile of women’s health in the United States, 3rd edition, Jacobs Institute of Women’s Health and the Henry J. Kaiser Family Foundation 2001:23 – 24..                         4.1                                                                                       

 

                                    Speroff L, Glass R, Kase N. Clinical Gynecologic Endocrinology and Infertility, 6th edition, edited by Mitchell C.: Lippincott, Williams and Wilkins, 1999: 1110-1117………………………………………...4.2

 

                              Stenchever M. Atlas of Clinical Gynecology: Reproductive Endocrinology, edited by Mishell DR.: Appleton and Lange: 1998: 3: 13.1 – 13.18………………………………………………………            4.3

                                   

                                    Stenchever M, Droegemueller W, Herbst A, Mishell DR. Comprehensive Gynecology, 4th edition, Mosby, Inc., 2001: 1169 – 1215……………………………………………………………… 4.4

 

                                    Toner J. Progress we can be proud of: U.S. trends in assisted reproduction over the first 20 years. Fertility and Sterility 2002: 78 (5): 943 – 950…………………………………………………………           4.5

 

                                    No authors listed. 2000 Assisted Reproductive Technology Success Rates: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services: 2002: 10 – 43………………………                   4.6

 

Tab 5                        Labels

 

                                    Label 1: Pergonalฎ………………………………………………… 5.1

                                    Label 2: Metrodinฎ………………………………………………... 5.2

                                    Label 3: Fertinexฎ…………………………………………………. 5.3

                                    Label 4: Repronexฎ………………………………………………..  5.4

                                    Label 5: Follistimฎ………………………………………………… 5.5

                                    Label 6: Gonal-Fฎ…………………………………………………. 5.6