FierceBiotech – The FDA has created a policy framework for cellular therapies and other regenerative medicines by releasing two draft and two final guidance documents. Publication of the texts builds on the 21st Century Cures Act by setting criteria for the new Regenerative Medicine Advanced Therapy (RMAT) designation and outlining the benefits of the regulatory status.
Given two of the documents are finalized versions of existing texts and a third seeks to simplify the regulation of devices that enable regenerative treatments, the RMAT guidance (PDF) is the novel part of the framework for drug developers. In the guidance, the FDA takes the RMAT status created by the 21st Century Cures Act, contextualizes it against other regulatory designations and explains how and why companies may want to apply.
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