FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies 2016 is a seminar that covers topics such as:
- 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
FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies 2016 is intended for professionals in stem cell, biotech, pharmaceutical and animal drug companies, veterinary hospitals and clinics.
