Food and Drug Administration
September 29, 2003
Briefing Information
Table of Contents (HTM) (PDF) (Word)
Introduction (HTM) (PDF) (Word)
Definitions (HTM) (PDF) (Word)
Human Gonadotropins: A Regulatory Perspective, Dr. Shelley Slaughter, MD, PhD, FDA (HTM) (PPT)
Bibliography (HTM) (PDF) (Word)
Pergonal® (Menotropins for Injection, USP) for Intramuscular Injection (PDF)
Metrodin® (Urofollitropin for Injection) for Intramuscular Injection (PDF)
Fertinex® (Urofollitropin for Injection, Purified) for Subcutaneous Injection (PDF)
Repronex® (Menotropins for Injection, USP) Package Insert (PDF)
Follistim® (Organon) (Follitropin Beta for Injection) for Subcutaneous and Intramuscular Use Only (PDF)
Gonal-F® (Serono) (Follitropin Alfa for Injection) for Subcutaneous Injection (PDF)