Food and Drug Administration

Pediatric Advisory Committee

June 30, 2005

Slides

Charge to the Committee and Overview of the Agenda: Concerta® and Methylphenidate Products, Solomon Iyasu, MD, MPH, FDA (HTM) (PPT)

FDA Pediatric Advisory Committee Presentation, Marsha Rappley, MD (HTM) (PPT)

Cytogenetic Effects of Methylphenidate, David Jacobson-Kram, PhD, DABT, FDA (HTM) (PPT)

Methylphenidate Regulatory History, Paul Anderson, MD, FDA (PDF) (PPT)

FDA Pediatric Advisory Committee Presentation, Ron Kavanagh, BS Pharm, PharmD, PhD (PPT)

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

Statement on Concerta and Methylphenidae, Dr. Murphy (HTM) (PPT)

Open Public Hearing

AACAP Comments (HTM) (PPT)