Cellular Biologics 2020 - FDA’s Regulation Human Cellular Biologics including Preclinical and First-In-Human Considerations Webinar

Regenerative medicine including stem cell therapy focuses on harnessing the power of one’s own stem cells and regenerative capabilities to restore function to damaged cells, tissues and organs; and by extension repair injuries and treat disease
There has also been significant enforcement action in the area as industry seeks to comply with the regulatory requirements and market their products to the public.
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.
Speaker:
Karl focuses his practice in FDA Regulatory law, representing U.S. and international clients in the food and drug industries with regard to pharmaceuticals and OTC drugs