The ISSCR supports the increase in biomedical research funding in the 21st Century Cures Act recently signed into law in the U.S., including NIH funding for scientific advances and clinical research that are key to improving public health.
We applaud the focus on regenerative therapies, and the definition of this class of medicine, which will play an increasing role in healthcare. Further, we are pleased that the Food and Drug Administration (FDA) continues its authority to provide accelerated approval and oversight as these therapies are developed. Of paramount concern is that the streamlined process for FDA review and approval outlined in the bill should not compromise the rigorous review of scientific and clinical evidence required to ensure the safety and efficacy of regenerative therapies.
We look forward to helping advance scientific discovery and the development of regenerative therapies that provide patients with safe, reliable treatments, recognizing that for many patients with currently incurable conditions these new medicines may uniquely offer the possibility for a healthy life.