Meeting Agenda

GENERAL AND PLASTIC SURGERY DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

 

Walker/Whetstone Rooms, Gaithersburg Holiday Inn

Two Montgomery Village Ave.

Gaithersburg, Maryland

November 21, 2003

 

Panel Acting Chairperson:                                                   Executive Secretary:

Phyllis Chang, MD                                                                                            David Krause, PhD

 

 

8:00 am                 Call to Order

 

Conflict of Interest, Temporary Voting Member Deputization and Opening Remarks

David Krause, PhD, Executive Secretary

 

Panel Introductions

Phyllis Chang, MD, Acting Chairperson

 

Update Since Last Meeting

CDR Stephen Rhodes, Branch Chief, Plastic and Reconstructive Surgery Devices Branch

8:15 am                 Open Public Comment

Elizabeth Santoro

Dr. Diana Zuckerman

Dr. N.J. Lowe

 

8:30 am                 Applicant Presentation, Q-Med AB, Restylane

Jur Strobos, MD, Council to Medicis

Bengt Agerup, CEO, Q-Med AB

Kjell Rensfeldt, MD, Medical Director, Q-Med Aesthetics

James Layden, MD, Professor of Dermatology, Univ. of Penn. School of Medicine

Paul Lorenc, MD, Asst. Professor of Plastic Surgery, NY University Medical Center

 

9:45 am                 Break

 

10:00 am                FDA Presentation

 

Introduction and Preclinical

Anthony D. Watson

 

Clinical Review

Roxolana Horbowyj, MD

 

Statistical Review

Telba Irony, PhD

 

10:45 am               Panel Deliberations and Address FDA Questions

 

11:15 am               Open Public Comments

Dr. A.W. Klein

Jill Follows

Dr. Trevor Born

 

11:30 am                FDA and Sponsor Summations, Concluding Panel Deliberations and Vote

 

 12:00 pm                Lunch

 

1:00 pm                 Call to Order

 

1:15 pm                 Open Public Comments

Dr. Diana Zuckerman

 

1:30 pm                 Applicant Presentation, Genzyme Corporation, Hylaform

 

Introduction

Sue Stewart, Vice President, Regulatory Affairs

 

Preclinical Review

James W. Burns, PhD, Senior Vice President, Biomaterials Research

 

Clinical Study Design

Richard P. Polisson, MD, MSHc, Senior Vice President, Clinical Research

 

Clinical Study Results

Lena Holmdahl, MD, PhD, Senior Director, Clinical Research

Conclusion
Susan Stewart

 

2:45 pm                 Break

 

3:00 pm                 FDA Presentation

 

Introduction and Clinical Review

Herbert Lerner, MD

 

Preclinical Review

David Krause, PhD

 

Statistical Review

Phyllis Silverman, MS

 

3:45 pm                 Panel Deliberations and Address FDA Questions.

 

4:00 pm                 Open Public Comments

 

4:15 pm                 FDA and Sponsor Summations, Concluding Panel Deliberations and Vote.

 

5:00 pm                 Adjournment