Food and Drug Administration

Pediatric Advisory Committee

June 29, 2005

Slides

Precursor Preference in Surfactant Synthesis of Newborns, Sara Goldkinds, MD, MA, FDA (HTM) (PPT)

Overview of FDA's Pediatric Advisory Committee Activities, Dianne Murphy, MD, FDA (HTM) (PPT)

Overview of the Agenda and the Role of the Committee in BPCA Safety Review, Solomon Iyasu, MD, MPH, FDA (HTM) (PPT)

One Year Post-Exclusivity Adverse Event Review: Norgestimate/ethinyl estradiol, Hari Sachs, MD, FAAP, FDA and Jean Temeck, MD, FAAP, FDA (PDF) (PPT)

One Year Post-Exclusivity Adverse Event Review: Tolterodine, Lawrence Grylack, MD, FDA (PDF) (PPT)

One Year Post-Exclusivity Adverse Event Review: Ciprofloxacin, Alan Shapiro, MD, PhD, FAAP, FDA (PDF) (PPT)

One Year Post-Exclusivity Adverse Event Review: Paricalcitol, Zolmitriptan, Dorzolamide, and Leflunomide, Solomon Iyasu, MD, MPH, FDA (PDF) (PPT)