Crackdown On Bad Regenerative Medicine Actors By US FDA Could Benefit Honest Developers
The agency plans to offer a series of guidance documents on regenerative product development as enforcement against "unscrupulous actors" continues.
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The framework includes two draft guidance documents and two final guidances. One of the drafts, which focuses on the regulation of devices used with regenerative medicine, implements a provision of the 21st Century Cures Act and strongly suggests that most of these products will be regulated via class II.
Congress should broaden scope of the 21st Century Cures’ regenerative advanced therapies (RAT) program to include gene therapies and other innovative treatments for rare diseases, attorney Sasinowski says, suggesting such an expansion could be part of the PDUFA legislation.
The 21st Century Cures Act will require US FDA to create standards and an expedited approval process for regenerative medicine products. Trade group ARM supports the efforts.