Human Cellular 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
In April 2006, the U.S. Food and Drug Administration’s (“FDA”) implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products
How FDA is currently regulating regenerative therapies and products intended for human use in the U.S.
The New Drug Application (“NDA”) and the Biologic License Application (“BLA”) review and approval processes including a discussion of available
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, biologics, medical devices,