Food and Drug Administration

Psychopharmacologic Drugs Advisory Committee

June 16, 2003


WBC Monitoring for Clozapine, Dr. Judith Racoosin, MD, MPH, FDA (HTM) (PPT)

Introduction and Regulatory Overview, Dr. James Rawls, PharmD, Novartis Pharmaceuticals (HTM) (PPT)

Overview of Agranulocytosis, Dr. Stan Gerson, MD, Novartis Pharmaceuticals (HTM) (PPT)

Clozaril Monitoring Systems, Registry Data and Analyses, Dr. Vinod Kumar, MD, Novartis Pharmaceuticals (HTM) (PPT)

Quantitative Analysis of Data from Clozaril National Registry, Dr. Lawrence Hauptman, PhD, Novartis Pharmaceuticals (HTM) (PPT)

Consideration of Issues, Dr. John Kane, MD, Novartis Pharmaceuticals (HTM) (PPT)

Back-up Information, Novartis Pharmaceuticals (HTM) (PPT)

Generic Drugs Registry Data, Dr. Tarek Hammad, MD, PhD, MSc, MS, FDA (HTM) (PPT)

Open Public Hearing

Statement of Maureen Schweers on Behalf of The National Alliance for the Mentally Ill (PDF)

Rational Hematological Monitoring for Clozapine-Treated Patients, Dr. David Goldman, MD, et. al. (HTM) (PPT)