Meeting Agenda

GENERAL AND PLASTIC SURGERY DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

 

Ballroom Salons A, B, C, and D, Gaithersburg Hilton Hotel

620 Perry Parkway

Gaithersburg, Maryland

March 25, 2004

 

Panel Chairman:                                                                   Executive Secretary:

Michael Choti, 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

Michael Choti, MD, Chairman

 

Update Since Last Meeting

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

8:15 am                 Open Public Comment

 

9:15 am                 Applicant Presentation, Dermik Laboratories, Sculptra

 

Product History
Kimberley Forbes-McKean, Ph.D., Senior Director, Product Development and Commercialization - Dermik Laboratories

 

Lipoatrophy Condition
Marcus A. Conant, M.D., Medical Director - Dermatology/HIV Consultations

 

Non-clinical Data
Jeffrey Handler, Ph.D. DABT, Director, Drug Safety Assessment and Evaluation -
Dermik Laboratories

Clinical Data
Sharon Levy, M.D., Senior Medical Director, Scientific and Medical Affairs -
Dermik Laboratories

Sponsor-Investigator Studies
Peter Engelhard, D.O., Medical Director - Apex South Beach

Conclusions
Kimberley Forbes-McKean, Ph.D. Senior Director, Product Development and Commercialization - Dermik Laboratories

 

10:30 am                Break

 

11:00 am                FDA Presentation

Office of Device Evaluation/Division of General, Restorative & Neurological Devices

Introduction
Herbert P. Lerner, MD

Toxicology
David B. Berkowitz, PhD, VMD

Clinical
Herbert P. Lerner, MD

 

12:00 pm               Panel Deliberations and Address FDA Questions

 

12:30 pm               Lunch

 

1:30 pm                 Continue Panel Deliberations and FDA Question Discussion:

 

2:15 pm                 Open Public Comment

 

3:15 pm                 Break

 

3:30 pm                 FDA and Sponsor Summations, Concluding Panel Deliberations and Vote

 

5:00 pm                 Adjournment