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
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