FDA Presentations

Clinical Review

(PPT) (HTM)

Glenn Mannheim, M.D.

Medical Officer, Division of Psychiatry Products CDER, FDA

Modafinil for the Treatment of ADHD  

(PPT) (HTM)

Paul J. Andreason, M.D.

Deputy Director, Division of Psychiatry Products

CDER, FDA

Serious Adverse Cutaneous Reactions to Drugs 

(PPT) (HTM)  

Michael E. Bigby, M.D.

Associate Professor

Beth Israel Deaconess Medical Center

Cephalon Presentation

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Introduction

Victor Raczkowski, M.D.

Vice President, Worldwide Regulatory Affairs

Cephalon, Inc.

Overview of ADHD

Joseph Biederman, M.D.

Professor of Psychiatry

Massachusetts General Hospital

& Harvard Medical School

Clinical Pharmacology and Efficacy

Lesley Russell, M.R.C.P.

Senior Vice President, Worldwide Clinical Research

Cephalon, Inc.

General Safety                     

Srdjan Stankovic, M.D

Vice President, Neuroscience Clinical Research

Cephalon, Inc.

Benefit-Risk/Conclusions    

Lesley Russell, M.R.C.P.

Open Public Hearing Speakers

(PPT) (HTM)

Questions to the Committee

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FDA Back-up Slides

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Cephalon Back-up Slides

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