FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies 2016

Key Topics

• The distinction being made between human regenerative products and their regulation as drugs, biologics, devices, and combination products
• How FDA is currently regulating regenerative therapies and products intended for both human and veterinary use
• The option for obtaining designation and approval as Orphan Drug Product
• The New Drug Application ("NDA") and the Biologic License Application ("BLA") review and approval processes including a discussion of available options, application components, relevant meetings, timing, costs and approval requirements
• FDA’s regulation of some regenerative medicine products and accessories as Medical Devices
• Designing and conducting appropriate clinical trials to support the approval of regenerative therapies
• The labeling and marketing of regenerative products and therapies
• The Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) being applied by FDA to human regenerative products
• The current regulation of veterinary cellular treatments including autologous, allogeneic and xenogeneic cellular products in the United States
• The potential for enforcement action and recommendations for mitigating that risk

Who should Attend

Professionals in stem cell, biotech, pharmaceutical and animal drug companies, veterinary hospitals and clinics.