Resources
Training Opportunities
- FFMI fastPACE (a 4-week biomedical innovation and commercialization course designed for the busy medical academician with an early stage project)
- Education and Training programs available from MICHR
- SBIR/STTR Training from BBC Entrepreneurial Training & Consulting
- Tissue Engineering and Regeneration Grant (training grant) Tissue Engineering and Regeneration (TEAM) is an interdisciplinary research-intensive training program for individuals who wish to pursue careers in the oral sciences with a focus in the area of restoration of oral-craniofacial tissues.
Regenerative Medicine
- Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center
- C-DOCTOR
- California Institute of Regenerative Medicine
- McGowan Institute for Regenerative Medicine
- Wake Forest Institute for Regenerative Medicine
- Regenerative Medicine Foundation
- Tissue Engineering and Regenerative Medicine International Society
- American Academy and Board of Regenerative Medicine
- The Transplantation Society
- International Society for Stem Cell Research
- Biomedical Engineering Society
- Society for Biomaterials
- Materials Research Society
- Osteology Foundation
Manufacturing
- Advanced Regenerative Manufacturing Institute
- Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies – Proceedings of a Workshop
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)
- 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies
- FDA Guidance: Questions and Answers on Good Laboratory Practice (March 1998)
- FDA Compliance Program Guidance Manual 7348.808 Good Laboratory Practice (May 2018)
Medical Devices
- 21 CFR Part 812: Investigational Device Exemptions
- 21 CFR Part 814: Premarket Approval of Medical Device
- 21 CFR Part 820: Quality System Regulation
- FDA Guidance: Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices – Part: Evaluation and Testing within a Risk Management Process” (June 2016)
- FDA Guidance: General Considerations for Animal Studies for Medical Devices (Oct 2015)
- FDA Guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510 (k)] (Jul 2014)
- FDA Guidance: Evaluation of Devices Used with Regenerative Medicine Advanced Therapies (Feb 2019)
Meeting with the FDA
- FDA Compliance Program Guidance Manual 7348.808 Good Laboratory Practice
- FDA Guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (May 2019)
Drugs
Cellular and Gene Therapy products
- FDA Guidance: Preclinical Assessment of Investigational Cellular and Gene Therapy Products (Nov 2013)
- FDA Guidance: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (Dec 2011)
- FDA Guidance: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use (Dec 20, 2017)