September 18-19, 2000



September 19, 2000

Food and Drug Administration

Medication Guides, Nancy M Ostrove PhD

Drug-Induced Depression, Erick Turner, MD

Positive Rechallenge Cases of Accutane - Associated Depressive Symptoms, Marilyn R Pitts, PharmD

Summary of Reported Cases of Suicide and Depression in US Accutane-Treated Patients, Diane K Wysowski, PhD

Important Tools in Determining Whether a Signal Warrants Further Investigation, Kathryn O'Connell, MD, PhD

Hormonal Contraceptive Interaction Studies and New Formulation PK, E Dennis Bashaw, PharmD

Safety and Efficacy Comparison Trial, Kathryn O'Connell, MD, PhD

Hoffmann-La Roche Inc.

Introduction & Risk Management, Russell Ellison, MD, Roche Laboratories, Inc ppt html

Overview of Psychiatric Disorders & Clinical Analysis of Spontaneous Reports, Douglas Jacobs, MD, Harvard Medical School ppt html

Accutane-Psychiatric Disorders: A Pharmacoepidemiological Safety Assessment, Robert C Nelson, PhD, RCN Associates Inc ppt html

Psychiatric Conditions Attempts to Confirm Signal, John McLane, PhD, Roche Medical Science and Safety ppt html

A New Once-Daily Formulation of Isotretinoin Accutane NF, John McLane, PhD, Roche Medical Science and Safety & David Young, PharmD, PhD, GloboMax LLC ppt html

Accutane and Psychiatric Illness, Liam Grant, Roaccutane Action Group, Ireland   ppt  html