Food and Drug
Administration
Reproductive Health Drugs Advisory Committee
August 29, 2006
Slides
17-Hydroxyprogesterone Caproate(Gestiva) Proposed Indication,
Scott Monroe, MD, CDER, FDA (ppt)
(htm)
Causes of Preterm Birth:“The Preterm Parturition Syndrome,”
Roberto Romero, M.D., NIH (ppt)
(htm)
17 ?-Hydroxyprogesterone Caproate Injection, 250 mg/mLNDA
21-945, Durlin E Hickok, MD, MPH, Adeza Biomedical (ppt)
(pdf)
NDA 21-945 17a Hydroxyprogesterone Caproate (Gestiva), Barbara
Wesley, M.D., M.P.H., CDER, FDA ((ppt)
(htm)
Statistical Presentation, Danial Gillan, Ph.D., UC Irvine
(pdf)
Open Public Comments
Preterm Labor and Birth:A Nurse’s Perspective, Barbara
Dehn RN, MS, NP (ppt)
(htm)
Progesterone & Prevention of Preterm Delivery, Michael
Paidas, M.D. (ppt)
(htm)
New Drug Application for “Gestiva” 17 alpha-hydroxyprogesterone
caproate (17 P), Theresa Grossklaus, RN, BA, BSN (ppt)
(htm)
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