Congress should use the forthcoming user fee reauthorization to both clarify and expand provisions in the 21st Century Cures Act aimed at spurring development of regenerative medicines and targeted rare disease drugs, one industry lawyer believes.
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.
