International Perinatal Stem Cell Society recommends US stem cell framework updates, including adopting Japan's risk model, new regulatory pathway, and allowing patient payments in trials.
International Perinatal Stem Cell Society calls for updates to US stem cell regulatory framework. The Society argues that the current system is holding back regenerative medicine advances, proposing changes such as adopting Japan's three-tier risk model, introducing a new regulatory pathway for 'medium risk' products, and allowing clinical trial sponsors to charge patients for participation in certain trials. The Society aims to restore the US as a global leader in regenerative medicine and biotechnology development while improving healthcare options and safety standards.
August 06, 2024
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