Regulating new regenerative therapies: FDA kicks off the process of recognizing voluntary standards
Thanks to the 21st Century Cures Act, the FDA has to identify certain voluntary standards to help speed the development of regenerative therapies, which are generally defined by the agency as cell-, gene- and tissue-based therapies to treat, modify, reverse, or cure a disease.
Modeled after a similar program used for medical devices, CBER this week published new draft guidance explaining how its mission to identify and recognize Voluntary Consensus Standards (VCS) will help make the development and assessment of so-called regenerative medicine therapies, or RMTs, more efficient and predictable.
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