FDA's Regulation of Regenerative Medicine

Call for Papers

• 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