Will US FDA User Fee Reauthorization Bring More RATS?
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.
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The agency plans to offer a series of guidance documents on regenerative product development as enforcement against "unscrupulous actors" continues.
US FDA to offer series of guidances on regenerative product development – and declares gene therapies eligible for RMAT – as enforcement against 'unscrupulous actors' continues.
CBER Director Peter Marks says center will mobilize necessary resources to make sure these provisions are implemented; Marks also offered comments in opposition to 'right-to-try' legislation.