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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/mL NDA 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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