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U.S. Department of Health and Human Services

Combination Products

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Meetings, Conferences, & Workshops

Meeting Agenda and Presentations

FDA/DIA Workshop: Combination Products and Mutually Conforming Labeling

Tuesday, May 10, 2005

 

AGENDA

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8:30 - 9:30 am 

Welcome and Introduction

Mark Barnett

Moderator

Assistant Director for Education and Communication, CDRH, FDA

 

Opening Remarks

Murray M. Lumpkin, MD, MSc.

Acting Deputy Commissioner for International and Special Programs, FDA

 

Perspectives on Cross Labeling

Suzanne O’Shea, Esq.

Product Jurisdiction Officer

Office of Combination Products, FDA

PowerPoint presentation

 

9:30 - 11:00 am    Public Health Panel

 

Drug – Device Combination Issues: Oncology Perspective

Ramzi Dagher, MD

Medical Team Leader

Division of Oncology Drug Products

Office of New Drugs, CDER

PowerPoint presentation

 

Public Health Issues Related to Mutually Conforming Labeling: CDRH Perspective

Miriam Provost, PhD

Acting Director

Division of General and Restorative Devices

Office of Device Evaluation, CDRH

PowerPoint presentation

 

Combination Products and Mutually Conforming Labeling: Public Health Issues

Leighton Hansel

Abbott Laboratories

Medical Products Group

Manager, Global Standards

Speaking on behalf of AdvaMed

PowerPoint presentation

 

Combination Products and Mutually Conforming Labeling

David Eveleth, PhD

Executive Director, Medical and Development Sciences

Pfizer, Inc

PowerPoint presentation

 

Grand Rounds 2005

Paul M. Goldfarb, MD, FACS

Consulting Medical Director

Genetronics, Inc .

Speaking on behalf of the Combination Products Coalition

PowerPoint presentation

 

Donna Bea-Tillman, PhD

Director

Office of Device Evaluation, CDRH

 

John Jenkins, MD

Director

Office of New Drugs, CDER

 

Celia Witten, MD, PhD

Director

Office of Cellular, Tissues and Gene Therapies, CBER

 

11:00 – 11:15 am    BREAK

 

11:15 – 12:30 pm    Open Discussion on Public Health Issues

 

12:30 - 1:30 pm    LUNCH

 

1:30 – 3:00 pm    Legal Panel

Legal Considerations in Cross Labeling Policy

Nancy Stade, Esq.

General Attorney

Office of the Chief Council, FDA

PowerPoint presentation

 

Cross-Labeling: Legal and Regulatory Issues

David M. Fox

Partner

Food, Drug, Medical Device, and Agriculture Practice Group

Hogan & Hartson LLP

PowerPoint presentation

 

FDA’s Role in Encouraging Innovation in Combination Products

Anna Longwell

Regulatory Counsel

Roche Diagnostics

Speaking on behalf of the Combination Products Coalition

PowerPoint presentation

 

Combination Products and Mutually Conforming Labeling: Legal Issues

Kathryn L. Gleason, Partner

Morgan, Lewis & Bockius LLP

Speaking on behalf of AdvaMed

PowerPoint presentation

 

Ann Wion, JD

Deputy Chief Counsel for Program Review

Office of the Chief Council, FDA

 

Diane Maloney, JD

Associate Director for Policy, CBER

 

Jane Axelrad, JD

Director

Office of Regulatory Policy, CDER

 

Joanne Less, PhD

Associate Director for Clinical Research and Government Affairs, CDRH

 

3:00 – 3:30 pm    BREAK

 

3:30 – 5:00 pm    Open Discussion on Legal Issues

 

CLOSING REMARKS

Mark Kramer

Director

Office of Combination Products

 

 

5:00 pm    Workshop Adjourned