2020 - FDA's Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering

Fundamentals of stem cells
How to control stem cell differentiation
Sources of stem cells
Incorporating stem cells into biomaterials
Avoiding immune system clearance of stem cells
FDA regulatory approach for the use of stem cells in medicine
Currently approved/accepted uses of stem cells in medicine
FDA guidance documents for stem cell technologies
Global approval of stem cell technologies (emphasis on EMA, Japan, China, India and Canada)
How the FDA regulates regenerative treatments and therapies
The use of human cells, tissues, and cellular and tissue-based (HCT/P) products and FDA’s regulatory framework
Use of non-HCT/P therapeutic materials (e.g., PRP and BMC) in the US
The drug and biological approval process
Regenerative products as medical devices
How to design appropriate clinical trials with an emphasis on stem cell-based materials
Applicable good manufacturing and good laboratory practices
Product labeling, marketing and advertising
FDA and other federal agency enforcement action
Future thoughts on approaches for regulatory approval of stem cell technologies
Remaining hurdles
Outlook for new technologies