Resources

Training Opportunities

Regenerative Medicine

Manufacturing

Standards

  • The Regenerative Medicine Standards Landscape: This report provides a snapshot of the current landscape for regenerative medicine standards. It outlines existing and in-development standards, providing a reference that individual organizations can use to identify available standards to improve their operations.
  • Needed Standards in Regenerative Medicine: Community Perspectives: Needed Standards in Regenerative Medicine report. The objective of the report is to outline standards needs identified by the community that could have the greatest benefit to the field and improve the safety and quality of regenerative medicine products.

FDA Regulations

Good Laboratory Practice (GLP)

Medical Devices

Meeting with the FDA

Drugs

Cellular and Gene Therapy products

Other FDA Guidance