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 (Link to 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 (Link to 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 (Link to 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 (Link to PowerPoint presentation) Combination Products and Mutually Conforming Labeling David Eveleth, PhD Executive Director, Medical and Development Sciences Pfizer, Inc (Link to PowerPoint presentation) Grand Rounds 2005 Paul M. Goldfarb, MD, FACS Consulting Medical Director Genetronics, Inc . Speaking on behalf of the Combination Products Coalition (Link to 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 (Link to PowerPoint presentation) Cross-Labeling: Legal and Regulatory Issues David M. Fox Partner Food, Drug, Medical Device, and Agriculture Practice Group Hogan & Hartson LLP (Link to 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 (Link to PowerPoint presentation) Combination Products and Mutually Conforming Labeling: Legal Issues Kathryn L. Gleason, Partner Morgan, Lewis & Bockius LLP Speaking on behalf of AdvaMed (Link to 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

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