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Will US FDA User Fee Reauthorization Bring More RATS?

 
• By Sue Sutter

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.

Capitol House

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.

The establishment of a designation process and approval pathway for regenerative advanced therapies in Cures should be broadened to gene therapies and other types of innovative treatments, Frank Sasinowski, a...

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