文档介绍：FDA Regulation bination Products
Barbara D. Boyan, .
American Academy of Orthopaedic Surgeons
Professor and Deputy Director for Research for the ia Tech/Emory Center for the Engineering of Living Tissues
November 25, 2002
AAOS has mitment to quality care and patient safety initiatives.
AAOS suggestions for the regulation bination products.
Decrease regulatory burden
Combination products provide unique challenges to FDA- under current scheme it will be difficult to get products to market.
Large start up capital
Tissue-engineered products have a smaller potential market (except cartilage subs.)
2 panies filed for bankruptcy- regulatory problems
Coordinate with CMS
Team Approach
Both in-house and 3rd party reviews
Multidisciplinary Coordination
Materials Scientist
Biologist
Clinician
Engineer
Odd number of reviewers
Sponsor should have the opportunity to provide additional information with the FDA Homework packet
Focus more on safety than effectiveness
Effectiveness could take 10-20 years in orthopaedic products.
Single and consistent regulatory pathway over time.
For mode of action in bone products-
Osteogenesis
Cellular elements, either from the host or from the TE product, which survive transplantation and synthesize new bone at recipient site.
Osteoinduction
New bone realized through the active recruitment of host mesenchymal stem cells from the surrounding tissue, which differentiate into bone-forming osteoblasts or form bone by endochondral ossification. Facilitated by presence of growth factors, principally BMPs.
Osteoconduction
The facilitation of blood-vessel incursion and new-bone formation into a defined trellis structure
Use foresight in preparing for global harmonization
CBER should work with the TEMPS mittees of ASTM on tissue standards
Several standards have already been finalized
Encourage global harmonization efforts
Create Advisory Panel
Consider the establishment of an FDA Advisory Panel with biological and device expertise