The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) hosted the Regenerative Medicine Innovation Workshop on Dec. 6-7, 2017, in Rockville, MD. The workshop explored the field of regenerative medicine using adult stem cells and approaches to advance clinical research while ensuring interventions are safe and effective.
Both Francis S. Collins, MD, PhD, Director of the NIH, and Scott Gottlieb, MD, Commissioner of the FDA, provided introductory remarks during the workshop. Each noted the progress in implementing the Regenerative Medicine Innovation Project (RMIP), established through the 21st Century Cures Act as a collaboration between the NIH and FDA. Congress has authorized $30 million in funding for RMIP over four years and in year one of the project (fiscal year 2017), NIH issued eight awards totaling $4.7 million. Additionally, on Nov. 16, the FDA issued four guidance documents outlining the regenerative medicine policy framework.
The advancement of regenerative medicine was again a topic the following day, Dec. 7, when Dr. Collins and Dr. Gottlieb testified before the Senate Committee on Health, Education, Labor, and Pensions at the Dec. 7 hearing on the Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation. The House Energy and Commerce Health Subcommittee held a similar hearing on Nov. 30.