Food and Drug Administration
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