Meeting Agenda


of the



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



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

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