Food and Drug Administration

Pediatric Advisory Committee

September 15, 2004

Slides

Summary of Pediatric Clinical Trial Data: Fluticasone and Budesonide, Dr. ShaAvhrée Buckman, MD, PhD, FAAP, FDA (PDF) (PPT)

Summary Comments - Orally Inhaled and Intranasal Budesonide and Fluticasone Propionate Drug Products, Dr. Badrul Chowdhury, MD, PhD, FDA (HTM) (PPT)

One Year Post Exclusivity Adverse Event Review: Desloratadine, Dr. Jame Fillie, MD, FDA (PDF) (PPT)

Adverse Event Tracking as Mandated by the Best Pharmaceuticals for Children Act, Dr. Solomon Iyasu, MD, MPH, FDA (PDF) (PPT)

One Year Post Exclusivity Adverse Event Review: Fludarabine, Dr. Susan McCune, MD, FDA (PDF) (PPT)

One Year Post Exclusivity Adverse Event Review: Ofloxacin Ophthalmic, Dr. Hari Sachs, MD, FAAP, FDA (PDF) (PPT)

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

Regulatory History, Labeling Changes, and Perspective on Safety for Orally Inhaled and Intranasal Budesonide and Fluticasone Propionate Drug Products, Dr. Peter Starke, MD FAAP, FDA (HTM) (PPT)

One Year Post Exclusivity Adverse Event Review: Budesonide & Fluticasone, Dr. Joyce Weaver, PharmD, BCPS, FDA (PDF) (PPT)