Food and Drug Administration

Anti-Infective Drugs Advisory Committee

Pediatric Subcommittee

June 9, 2004

Slides

One Year Post Exclusivity Adverse Event Review as Mandated by the Best Pharmaceuticals for Children Act, Dr. Solomon Iyasu, MD, MPH, FDA (HTM) (PPT)

One Year Post Exclusivity Adverse Event Review: Fexofenadine, Dr. Jane Filie, MD, FDA (HTM) (PPT)

One Year Post Exclusivity Adverse Event Review: Topotecan, Dr. Susan McCune, MD, MA Ed, FDA (HTM) (PPT)

One Year Post Exclusivity Adverse Event Review: Ciprofloxacin, Dr. J. Gunkel, MD, FDA (HTM) (PPT)

One Year Post Exclusivity Adverse Event Review: Fosinopril, Dr. Lawrence Grylack, MD, FDA (HTM) (PPT)

One Year Post Exclusivity Adverse Event Review: Fentanyl Transdermal System, Dr. ShaAvhrée Buckman, MD, PhD, FAAP, FDA (HTM) (PPT)

Fentanyl Pharmacokinetic Characteristics Following Duragesic® Application, Dr. David Lee, PhD, FDA (HTM) (PPT)

Comments on Adverse Event Review: Fentanyl Transdermal System, Dr. D. McNeil, MD, FDA (HTM) (PPT)

One Year Post Exclusivity Adverse Event Review: Venlafaxine, Dr. Hari Sachs, MD, FAAP, FDA (HTM) (PPT)

Neonatal Withdrawal Syndrome With Serotonin Reuptake Inhibitors, Office of Drug Safety Reveiw, Dr. Kathleen Phelan, R.Ph, FDA (HTM) (PPT)

Neonatal Adverse Events Associated With in Utero SSRI/SNRI Exposure, Dr. Robert Levin, MD, FDA (HTM) (PPT)

Neonatal Antidepressant Effects, Dr. Katherine Wisner, MD, MS, University of Pittsburgh Medical Center (HTM) (PPT)

Update on Congenital Eye Malformations, Dr. Solomon Iyasu, MD, MPH, FDA (HTM) (PPT)

Pediatric Research Equity Act, Dr. Shirley Murphy, MD, FDA (HTM) (PPT)

The Ethical Conduct of Clinical Research Involving Children, Dr. Robert Nelson, MD, PhD, The Children's Hospital of Philadelphia (HTM) (PPT)

Questions (HTM) (PPT)

Open Public Hearing

Maternal SSRI-Use During Pregnancy and Neonatal Neurobehavioral Outcome, Dr. Philip Zeskind, PhD, Carolinas Medical Center-Charlotte (HTM) (PPT)