The Alliance for Regenerative Medicine (ARM) held a webinar on February 2, 2017, titled “Understanding the 21st Century Cures Act for Cell & Gene Therapies.” During this one-hour live event, Michael Werner, Executive Director for ARM was joined by Director Wilson Bryan and Deputy Director Rachael Anatol of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT), as well as Anne-Virginie Eggimann, Vice President of Regulatory Science for bluebird bio, to provide an overview of several provisions within the 21st Century Cures Act. The legislation, which was signed into law on December 13, 2016, introduced, for the first time in the U.S., a specific Regenerative Medicine/Advanced Therapy (RMAT) product designation, as well as regenerative medicine-specific language intended to optimize the FDA’s approval pathways for regenerative medicine products, without reducing the agency’s high approval standards for product safety and efficacy.
See the FDA’s recent statement on how it intends to implement the new RMAT designation here.
Rachael Anatol, Ph.D., Deputy Director, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA)
Wilson Bryan, M.D., Director, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA)
Anne-Virginie Eggiman, VP, Regulatory Science, bluebird bio
Michael Werner, Executive Director, Alliance for Regenerative Medicine
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