Combination Products

Meeting Agenda and Presentations, FDA/DIA Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling

FDA/DIA Workshop: Combination Products and Mutually Conforming Labeling

Tuesday, May 10, 2005

AGENDA


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 Workshop Adjourned

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