Combination Products
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
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
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
Combination Products and Mutually Conforming Labeling: Public Health Issues
Leighton Hansel
Abbott Laboratories
Medical Products Group
Manager, Global Standards
Speaking on behalf of AdvaMed
Combination Products and Mutually Conforming Labeling
David Eveleth, PhD
Executive Director, Medical and Development Sciences
Pfizer, Inc
Grand Rounds 2005
Paul M. Goldfarb, MD, FACS
Consulting Medical Director
Genetronics, Inc .
Speaking on behalf of the Combination Products Coalition
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
Cross-Labeling: Legal and Regulatory Issues
David M. Fox
Partner
Food, Drug, Medical Device, and Agriculture Practice Group
Hogan & Hartson LLP
FDA’s Role in Encouraging Innovation in Combination Products
Anna Longwell
Regulatory Counsel
Roche Diagnostics
Speaking on behalf of the Combination Products Coalition
Combination Products and Mutually Conforming Labeling: Legal Issues
Kathryn L. Gleason, Partner
Morgan, Lewis & Bockius LLP
Speaking on behalf of AdvaMed
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
