Food and Drug Administration

Pediatric Advisory Committee

March 22, 2006

Slides

Overview of Pediatric Safety Reporting and Role of the Committee, Solomon Iyasu, M.D., M.P.H. (ppt) (htm)

One Year Post-Exclusivity Adverse Event Review:Clofarabine, Lawrence Grylack, M.D., FDA (ppt) (htm)

One Year Post-Exclusivity Adverse Event Review:Irbesartan, Alan M. Shapiro, MD, PhD, FAAP, FDA (ppt) (htm)

Regulatory History of Sibutramine, Eric Colman, MD, FDA (ppt) (htm)

One Year Post Exclusivity Adverse Event Review:Sibutramine, Hari Cheryl Sachs, MD, FAAP, FDA (ppt) (htm)

Pediatric Advisory Committee and ADHD Products, Dr. Dianne Murphy, FDA (ppt) (htm)

New Physician’s Labeling: Where is the Safety Information?, Rosemary Roberts, MD, FAAP, FDA (ppt) (htm)

Summary of June 2005 PAC-Interim Actions and Landmark Events, Paul J. Andreason, MD, FDA (ppt) (htm)

On the Efficacy of Pharmacological Treatment of Attention Deficit Hyperactivity Disorder, Benedetto Vitiello, M.D., FDA (ppt) (htm)

One Year Post Exclusivity Adverse Event ReviewADDERALL XR®, Susan K. McCune, M.D., FDA (ppt) (htm)

Use of Drugs for ADHD in the United States, Andrew D. Mosholder, M.D., M.P.H., FDA (ppt) (htm)

Cardiovascular Risk with Drug Treatments of ADHD, Kate Gelperin, M.D., M.P.H., FDA (ppt) (htm)

ADHD drugs and CV outcomes:Preliminary feasibility results and potential observational studies, David J. Graham, MD, MPH (ppt) (htm)

Psychiatric Adverse Events in Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trials, Andrew D. Mosholder, M.D., M.P.H., FDA (ppt) (htm)

Psychiatric Adverse Events with Drug Treatments of ADHD, Kate Gelperin, M.D., M.P.H., FDA (ppt) (htm)

CONCERTA® (methylphenidate HCl)Extended-Release Tablets, McNeil Presentation (ppt) (htm)

Assessing Drug Safety and ADHD Medications, Including Atomoxetine, A. J. Allen, M.D., Ph.D., Eli Lilly Presentation (ppt) (htm)

Psychosis/Mania Events, Newman - MossHolder Tables (ppt) (htm)

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