Food and Drug Administration

Pediatric Advisory Committee

November 18, 2005

Slides

Overview and Recognition, Dianne Murphy, OPT, FDA (HTM) (PPT)

Overview of Pediatric Safety Reporting role of the Committee, Solomon Iyasu, MD, MPH, FDA (HTM) (PPT)

One Year Post-Exclusivity Adverse Event Review for Tamiflu® (oseltamivir), Melissa Truffa, RPh, FDA (HTM) (PPT)

Safety of Tamiflu in Pediatric Patients - Review of Clinical Trials Data and the Scientific Literature, Linda Lewis, MD (HTM) (PPT)

Summary of FDA Action Plan for Tamiflu Related to Pediatric Safety, Linda Lewis, MD, FDA (HTM) (PPT)

Surveillance among U.S. Children for Influenza-Related Mortality and Encephalopathy, David Shay, MD, MPH, CDC (PDF) (PPT)

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

One Year Post Exclusivity Adverse Event Review: Anagrelide, Hari Sachs, MD, FDA (PDF) (PPT)

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

One Year Post Exclusivity Adverse Event Review: Fluconazole, Hari Sachs, MD, FDA (PDF) (PPT)

One Year Post Exclusivity Adverse Event Review: Sodium ferric gluconate complex, Lawrence Grylack, MD, FDA (PDF) (PPT)

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

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

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Tamiflu (oseltamivir), Hoffman Roche (PDF)