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FDA Eyes Regenerative Medicine Push in Next User Fee Proposal

Sept. 24, 2021, 4:02 PM

An ambitious plan in the FDA’s next user fee agreement with drugmakers aims to bring more cutting-edge regenerative medicines to market through guidance, beefed up staffing, and public input, the agency’s policy and legislative deputy commissioner said.

“FDA recognizes the value of regenerative medicine and stands ready to help you advance promising cell tissue and gene therapy products to market,” Andi Lipstein Fristedt, deputy commissioner for policy, legislation, and international affairs, said Friday at the American Society of Cell & Gene Therapy’s policy summit.

“At the end of the day, we’re all focused on the same thing: bringing innovative ...

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