ARM commends the Biden administration for nominating Dr. Robert Califf as FDA commissioner at a momentous time for public health and the development of innovative technologies. Dr. Califf previously led the FDA when the Regenerative Medicine Advanced Therapy (RMAT) designation was established to expedite patient access to transformative cell and gene therapies. The agency this year has approved three therapies under the RMAT designation – the first to be approved under the pathway. Pending Senate confirmation, ARM looks forward to continuing our work with Dr. Califf and the Center for Biologics Evaluation and Research to deliver life-changing therapies that address the root causes of devastating diseases.