Investigator Training Resources

Resources

Task Force Report: American Society for Bone and Mineral Research‐Orthopaedic Research Society Joint Task Force Report on Cell‐Based Therapies

Awareness of the Role of Science in the FDA Regulatory Submission Process: A Survey of the TERMIS-Americas Membership

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.

Proceedings of NAS Cell Manufacturing Workshop

FDA Guidance on Regenerative Medicine

2 new FDA guidance documents on regenerative medicine therapies:

• Evaluation of Devices Used with Regenerative Medicine Advanced Therapies
• Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

1. Click here to see the press release.

• First Final Guidance
• Second Final Guidance
• First Draft Guidance
• Second Draft Guidance

Osteology Research Guidelines:  Online version of the book series, Osteology Guidelines for Oral & Maxillofacial Regeneration, where leading experts present their tried and tested study protocols and general aspects on preclinical and clinical research.

• Preclinical Models for Translational Research.  Editors –  Prof. William V. Giannobile and Prof. Myron Nevins
• Clinical Research.  Editors – William V.Giannobile, Niklaus P. Lang and Maurizio S. Tonetti

1. Please register (free of charge) at www.box.osteology.org
2. After you have registered, go to Science, and then to the Osteology Research Guidelines: https://box.osteology.org/science/osteology-research-guidelines

Preclinical Animal Models for Temporomandibular Joint Tissue Engineering